Medtronic Heart Valves: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Medtronic Heart Valves” (first 2003, latest 2006), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 79 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| KRH | Ring, Annuloplasty | 3 | 3 |
| LWR | Heart-Valve, Non-Allograft Tissue | 1 | 0 |
Review panels
- Cardiovascular (4)
Most recent Medtronic Heart Valves 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052970 | SIMPLICI-T ANNULOPLASTY SYSTEM | KRH | 2006-01-11 | 79 |
| K052860 | CG FUTURE ANNULOPLASTY BAND | KRH | 2005-11-10 | 30 |
| K032810 | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE | KRH | 2003-12-05 | 87 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P790007 | PMA | HANCOCK MODIFIED ORIFICE BIOPROSTHESIS | 1979-11-15 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Heart Valves.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Medtronic Heart Valves is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT02979587: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study (Active not recruiting, started 2017-01)
- NCT02347189: Melody PB1016 Surveillance Study (Completed, started 2014-11)
- NCT01762124: Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV) (Completed, started 2012-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Heart Valves?
FDA lists 3 510(k) clearances under the applicant name “Medtronic Heart Valves” (first 2003, latest 2006), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtronic Heart Valves?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Heart Valves is 79 days.
Which FDA product codes appear under Medtronic Heart Valves?
The most frequent FDA product codes under this applicant name are KRH (Ring, Annuloplasty, 3); LWR (Heart-Valve, Non-Allograft Tissue, 1).
Next steps
- See all 3 Medtronic Heart Valves clearances with predicates and recalls
- Run predicate analysis for product code KRH, Medtronic Heart Valves's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.