MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
FDA premarket approval P990064 · decided 2000-07-14
Approval details
- PMA number
- P990064
- Trade name
- MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 1999-10-08
- Decision date
- 2000-07-14
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR THE MOSAIC(R) PORCINE BIOPROSTHESIS, MODELS 305 AND 310 IN THE FOLLOWING SIZES: MODEL 305 (AORTIC) 21, 23, 25, 27 AND 29 MM; MODEL 310 (MITRAL) 25, 27, 29 AND 31 MM. THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL HEART VALVES.
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