FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
FDA premarket approval P970031/S014 · decided 2006-04-20
Approval details
- PMA number
- P970031
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 2005-12-27
- Decision date
- 2006-04-20
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF SMALLER CAPACITY EQUIPMENT AND ELIMINATION OF THE SHRINK TEMPERATURE TESTING USED FOR THE TISSUE FIXATION MANUFACTURING PROCESS.
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