PMA P860057S227
- Device
- Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis Model 2800; Carpentier-Edwards PERIMOUNT RSR Pericardi
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S227
- Product code
- DYE
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- a new sampling plan for in-process testing
Current openFDA PMA Record#
- Device
- Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis Model 2800; Carpentier-Edwards PERIMOUNT RSR Pericardi
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S227
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new sampling plan for in-process testing