Open Pivot Aortic Valved Graft
FDA premarket approval P990046/S059 · decided 2021-07-29
Approval details
- PMA number
- P990046
- Supplement
- S059
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Open Pivot Aortic Valved Graft
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2021-05-06
- Decision date
- 2021-07-29
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changes to the inner packaging design and extension of the shelf life.
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