CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300
FDA premarket approval P870056/S047 · decided 2012-04-04
Approval details
- PMA number
- P870056
- Supplement
- S047
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2012-03-05
- Decision date
- 2012-04-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR ADDING TEXT TO THE WARNINGS AND COMPLICATIONS SECTIONS OF THE EDWARDS MODEL 4300 VALVED CONDUIT IFU IN ORDER TO STRENGTHEN THESE STATEMENTS.
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510(k) clearances by this applicant
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