ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
FDA premarket approval P060025/S005 · decided 2010-07-13
Approval details
- PMA number
- P060025
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 2010-05-14
- Decision date
- 2010-07-13
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL OF THE POST-APPROVAL PROTOCOL.
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