Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve
FDA premarket approval P860057/S197 · decided 2020-06-23
Approval details
- PMA number
- P860057
- Supplement
- S197
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2019-12-26
- Decision date
- 2020-06-23
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a labeling change for the Carpentier-Edwards PERIMOUNT® Magna Ease® Aortic Heart Valve, model 3300TFX, to update the Instructions for Use (IFU) reflecting data from the completed Post-Approval Study.
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