MOSAIC PORCINE BIOPROSTHESIS
FDA premarket approval P990064/S028 · decided 2009-09-29
Approval details
- PMA number
- P990064
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOSAIC PORCINE BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2009-07-31
- Decision date
- 2009-09-29
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE DISPOSABLE CINCH AORTIC VALVE HOLDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CINCH II VALVE HOLDER AND IS INDICATED FOR THE TEMPORARY DEFLECTION OF THE VALVE STENT POSTS TO PROVIDE SURGICAL EASE OF IMPLANTATION OF THE BIOPROSTHESIS.
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