MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES
FDA premarket approval P980043/S005 · decided 2004-11-18
Approval details
- PMA number
- P980043
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2004-09-23
- Decision date
- 2004-11-18
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR ADDITIONAL PRODUCT LINES OF THE MOSAIC PORCINE BIOPROSTHESIS AND THE HANCOCK II BIOPROSTHESIS WHICH WILL USE SMALLER SEWING RING DIAMETERS.
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