PMA P200015S032
- Device
- Crimper
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S032
- Product code
- NPV
- Decision date
- 2022-12-12
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Implement in-house injection molding processes for Crimper subassemblies.
Current openFDA PMA Record#
- Device
- Crimper
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S032
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-12-12
- Decision code
- OK30
- Date received
- 2022-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement in-house injection molding processes for Crimper subassemblies.