- Device
- 9600CR Crimper
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S016
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-01-04
- Decision code
- APPR
- Date received
- 2021-11-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the Edwards Añasco Puerto Rico manufacturing site to manufacture the Crimper 9600CR, located at State Road 402, KM 1.4, Industrial Park, Añasco, PR 00610.