OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT
FDA premarket approval P990046/S047 · decided 2016-08-04
Approval details
- PMA number
- P990046
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2016-07-11
- Decision date
- 2016-08-04
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update to software used in the manufacturing process for the Open Pivot Heart Valve and Aortic Valved Graft.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.