MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
FDA premarket approval P990064/S065 · decided 2017-02-07
Approval details
- PMA number
- P990064
- Supplement
- S065
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2016-11-10
- Decision date
- 2017-02-07
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for changes to the labeling content and format for the Mosaic, Hancock II, and Freestyle Bioprostheses.
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