CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA premarket approval P860057/S012 · decided 1999-10-22
Approval details
- PMA number
- P860057
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Trade name
- CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 1999-10-04
- Decision date
- 1999-10-22
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid steriliztion in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process.
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