MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA premarket approval P970031/S004 · decided 1998-09-18
Approval details
- PMA number
- P970031
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 1998-01-12
- Decision date
- 1998-09-18
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for the protocols to be used for the short term and long term post approval studies.
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