MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC)
FDA premarket approval P990064/S007 · decided 2002-10-28
Approval details
- PMA number
- P990064
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC)
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2002-05-06
- Decision date
- 2002-10-28
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE VALVE HOLDERS FOR THE MOSAIC BIOPROSTHESIS. THE HOLDERS ARE TO BE USED WITH THE FOLLOWING APPROVED VALVE MODELS AND SIZES: MOSAIC PORCINE BIOPROSTHESIS, MODEL 305 (AORTIC, SIZES 19, 21, 23, 25, 27, AND 29 MM. THESE AORTIC VALVES ARE INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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