Medtronic Ats Medical, Inc.: FDA clearances and approvals
Medtronic Ats Medical, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. openFDA lists 5 product recalls by a recalling firm named Medtronic Ats Medical, Inc.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LWQ | Heart-Valve, Mechanical | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990046 | PMA | ATS OPEN PIVOT BILEAFLET HEART VALVE | 2000-10-13 |
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-10-12.
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.
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Ats Medical, Inc. have?
Medtronic Ats Medical, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Medtronic Ats Medical, Inc. make?
Its most frequent FDA product codes are LWQ (Heart-Valve, Mechanical, 1).
Has Medtronic Ats Medical, Inc. had device recalls?
openFDA lists 5 product recalls in 2 recall events by a recalling firm whose name matches Medtronic Ats Medical, Inc; the most recent began 2020-10-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 Medtronic Ats Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LWQ, Medtronic Ats Medical, 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.