American Medical Systems, Inc.: FDA clearances and approvals
American Medical Systems, Inc. has 82 FDA 510(k) clearances (first 1979, latest 2014), plus 1 PMA decision, across 28 product codes in 6 review panels. Median 510(k) review time: 75 days. openFDA lists 24 product recalls by a recalling firm named American Medical Systems, Inc. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 90 |
| 2013 | 2 | 152 |
| 2014 | 1 | 94 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 14 | 14 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 13 | 13 |
| FAE | Prosthesis, Penile | 11 | 11 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| KOE | Dilator, Urethral | 4 | 4 |
| EZN | Dilator, Catheter, Ureteral | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 3 | 3 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 3 | 3 |
| FAG | Prosthesis, Urethral Sphincter | 2 | 2 |
Plus 18 more product codes.
Review panels
- Gastroenterology and Urology (48)
- Obstetrics and Gynecology (16)
- General and Plastic Surgery (12)
- Orthopedic (4)
- Cardiovascular (2)
- General Hospital (1)
Most recent American Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | GEX | 2014-06-20 | 94 |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | OTN | 2013-12-05 | 219 |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | OTN | 2013-11-20 | 86 |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | OTO | 2012-10-16 | 119 |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | PAH | 2012-09-07 | 95 |
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | OTP | 2012-07-20 | 49 |
| K120870 | GREENLIGHT MOXY FIBER OPTIC | GEX | 2012-06-15 | 85 |
| K112842 | AMS ELEVATE PC | OTP | 2011-10-25 | 26 |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | OTP | 2011-07-01 | 71 |
| K100746 | FIBER ONE | GEX | 2010-06-11 | 87 |
72 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940012 | PMA | 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS | 1995-12-27 |
Recalls
24 product recalls in 15 recall events; 0 initiated in the last five years. Most recent: 2014-10-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
American Medical Systems, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01862601: JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers (Completed, started 2013-09)
- NCT00894933: Performance Evaluation of the AMS CONTINUUM™ Device (Completed, started 2009-05)
- NCT01083199: Global Performance Evaluation of the AMS CONTINUUM™ Device (Completed, started 2007-10)
- NCT00465101: A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization (Completed, started 2007-05)
- NCT00904969: A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence (Completed, started 2005-09)
Frequently asked questions
How many FDA 510(k) clearances does American Medical Systems, Inc. have?
American Medical Systems, Inc. has 82 FDA 510(k) clearances (first 1979, latest 2014), plus 1 PMA decision, across 28 product codes in 6 review panels.
How long does FDA take to clear American Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across American Medical Systems, Inc.'s cleared 510(k)s is 75 days.
What devices does American Medical Systems, Inc. make?
Its most frequent FDA product codes are OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 14); OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, 13); FAE (Prosthesis, Penile, 11).
Has American Medical Systems, Inc. had device recalls?
openFDA lists 24 product recalls in 15 recall events by a recalling firm whose name matches American Medical Systems, Inc; the most recent began 2014-10-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 82 American Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OTN, American Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.