MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL)
FDA premarket approval P990064/S004 · decided 2001-06-07
Approval details
- PMA number
- P990064
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL)
- Applicant
- Medtronic, Inc.
- Date received
- 2000-08-29
- Decision date
- 2001-06-07
- Days to decision
- 282 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE MEDTRONIC MOSAIC PORCINE BIOPROSTHESES, MODEL 305 (AORTIC) AND MODEL 310 (MITRAL).
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