PMA P200015S083
- Device
- Edwards Crimper (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S083
- Product code
- NPV
- Decision date
- 2026-09-23
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- adoption of the Edwards Crimper into an existing validated sterilization cycle
Current openFDA PMA Record#
- Device
- Edwards Crimper (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S083
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-09-23
- Decision code
- OK30
- Date received
- 2026-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adoption of the Edwards Crimper into an existing validated sterilization cycle