PMA P860057S135
- Device
- CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S135
- Product code
- DYE
- Decision date
- 2015-06-11
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR MODIFICATION (ELIMINATION) TO THE CENTRAIL-HOLE-IN-AIR SPECIFICATION.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S135
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2015-06-11
- Decision code
- APPR
- Date received
- 2015-03-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION (ELIMINATION) TO THE CENTRAIL-HOLE-IN-AIR SPECIFICATION.