PMA P860057S012
- Device
- CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S012
- Product code
- DYE
- Decision date
- 1999-10-22
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order 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.
Current openFDA PMA Record#
- Device
- CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S012
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 1999-10-22
- Decision code
- OK30
- Date received
- 1999-10-04
- Supplement type
- 30-Day Notice
- Approval order 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.