HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE
FDA premarket approval P980043/S048 · decided 2015-02-25
Approval details
- PMA number
- P980043
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2014-07-21
- Decision date
- 2015-02-25
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR A CHANGE TO THE STENT MATERIAL FROM ACETALHOMOPOLYMER (AHP) TO POLYETHERETHERKETONE, PEEK I5R (PEEK) FOR THE DEVICES.
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