MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310
FDA premarket approval P990064/S014 · decided 2006-06-05
Approval details
- PMA number
- P990064
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2006-02-06
- Decision date
- 2006-06-05
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE MOSAIC MITRAL BIOPROSTHESES, AND 4) THE "INSTRUCTIONS FOR USE": TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER.
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