FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995
FDA premarket approval P970031/S015 · decided 2006-08-28
Approval details
- PMA number
- P970031
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 2006-03-27
- Decision date
- 2006-08-28
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) BASED ON THE RESULTS OF THE COMPLETED POST-MARKET STUDY FOR THE DEVICE.
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