HANCOCK II BIOPROSTHESIS
FDA premarket approval P980043/S012 · decided 2007-08-29
Approval details
- PMA number
- P980043
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HANCOCK II BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2007-06-19
- Decision date
- 2007-08-29
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL TO REDUCE THE BIOPROSTHESIS RINSING TIME PRIOR TO IMPLANTATION. THE APPROVAL APPLIES TO ALL SIZES OF THE AORTIC AND MITRAL HANCOCK II BIOPROSTHESIS.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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