PMA P860057S070
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S070
- Product code
- DYE
- Decision date
- 2010-10-27
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- EXPANSION OF CLEAN ROOM #2 AT THE CHANGI, SINGAPORE MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S070
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2010-10-27
- Decision code
- OK30
- Date received
- 2010-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXPANSION OF CLEAN ROOM #2 AT THE CHANGI, SINGAPORE MANUFACTURING FACILITY.