PMA P860057S214
- Device
- Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S214
- Product code
- DYE
- Decision date
- 2023-12-11
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- implementation of the Optical Character Recognition Printing System
Current openFDA PMA Record#
- Device
- Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S214
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2023-12-11
- Decision code
- OK30
- Date received
- 2023-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of the Optical Character Recognition Printing System