Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft
FDA premarket approval P990046/S054 · decided 2018-07-11
Approval details
- PMA number
- P990046
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2018-06-22
- Decision date
- 2018-07-11
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Transfer of manufacturing operations to a different building within the same manufacturing site.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.