MOSAIC PORCINE BIOPROSTHESIS
FDA premarket approval P990064/S005 · decided 2001-11-21
Approval details
- PMA number
- P990064
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOSAIC PORCINE BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2001-04-02
- Decision date
- 2001-11-21
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR THE MOSAIC PORCINE BIOPROSTHESIS, MODEL 310 MITRAL, 33 MM.
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