3F AORTIC BIOPROSTHESIS, MODEL 1000
FDA premarket approval P060025/S012 · decided 2013-10-02
Approval details
- PMA number
- P060025
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 3F AORTIC BIOPROSTHESIS, MODEL 1000
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 2013-07-09
- Decision date
- 2013-10-02
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CHANGE TO THE PACKAGING SYSTEM FOR THE 3F AORTICBIOPROSTHESIS, MODEL 1000.
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