FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS
FDA premarket approval P970031/S010 · decided 2001-10-31
Approval details
- PMA number
- P970031
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 2001-05-03
- Decision date
- 2001-10-31
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, AVAILABLE IN SIZES 19 MM, 21 MM, 23 MM, 25 MM, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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