OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE
FDA premarket approval P990046/S016 · decided 2007-12-11
Approval details
- PMA number
- P990046
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2006-12-15
- Decision date
- 2007-12-11
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE MODELS AP360.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.