PMA P860057S151
- Device
- Carpentier-Edwards PERIMOUNT
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S151
- Product code
- DYE
- Decision date
- 2016-07-01
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- Use of an automated laser measurement system for in-process dimensional inspections.
Current openFDA PMA Record#
- Device
- Carpentier-Edwards PERIMOUNT
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S151
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2016-07-01
- Decision code
- OK30
- Date received
- 2016-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an automated laser measurement system for in-process dimensional inspections.