PMA P860057S208
- Device
- Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S208
- Product code
- DYE
- Decision date
- 2022-09-12
- Generic name
- replacement Heart-valve
- Approval order statement
- Outsource polyester band manufacturing steps currently performed in-house to an existing supplier.
Current openFDA PMA Record#
- Device
- Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S208
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2022-09-12
- Decision code
- OK30
- Date received
- 2022-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Outsource polyester band manufacturing steps currently performed in-house to an existing supplier.