Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
FDA premarket approval P860057/S189 · decided 2020-01-15
Approval details
- PMA number
- P860057
- Supplement
- S189
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2019-05-23
- Decision date
- 2020-01-15
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the use of the dry plant quality laboratory for routine environmental and manufacturing solution monitoring.
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510(k) clearances by this applicant
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|---|---|---|
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