PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES
FDA premarket approval P860057/S036 · decided 2007-01-08
Approval details
- PMA number
- P860057
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2006-07-19
- Decision date
- 2007-01-08
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO DECREASE THE MINIMUM LEAFLET TISSUE THICKNESS SPECIFICATION FOR THE 25MM AND 27MM VALVES.
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