FDA product code PAH: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
PAH is the FDA product code for mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 20 510(k) submissions under PAH, 2 in the last five years, from 13 different applicants. The average 510(k) review took 132 days (median 84); 59 days on average over the last three years. FDA has posted 1 recall for PAH devices.
Definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PAH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 255 |
| 2023 | 1 | 232 |
| 2024 | 1 | 59 |
Top PAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 4 | 2010-06-07 |
| Coloplast A/S | 2 | 2023-02-15 |
| Caldera Medical, Inc. | 2 | 2020-02-07 |
| C.R. Bard, Inc. | 2 | 2012-11-02 |
| Mpathy Medical Devices, Ltd. | 2 | 2009-07-14 |
8 more applicants have PAH clearances. See the full list in Caduvo.
Most recent PAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242473 | Coloplast Corp. | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | 2024-10-18 | 59 |
| K221874 | Coloplast A/S | Altis Single Incision Sling System | 2023-02-15 | 232 |
| K191416 | Caldera Medical, Inc. | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | 2020-02-07 | 255 |
| K121562 | Coloplast A/S | ALTIS SINGLE INCISION CLING SYSTEM | 2012-11-05 | 160 |
| K123179 | C.R. Bard, Inc. | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING | 2012-11-02 | 24 |
Recalls for PAH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-26.
Frequently asked questions
What is FDA product code PAH?
PAH is the FDA product code for mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Gastroenterology and Urology panel.
What device class is PAH?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAH?
Across 20 cleared submissions the average was 132 days from receipt to decision (median 84).
Which companies have the most PAH clearances?
American Medical Systems, Inc. (4); Coloplast A/S (2); Caldera Medical, Inc. (2); C.R. Bard, Inc. (2); Mpathy Medical Devices, Ltd. (2).
Have PAH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-10-26.
Next steps
- Run an FDA pathway report with predicate devices for product code PAH
- Run a recall and safety report across every PAH manufacturer
- Watch product code PAH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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