- Device
- Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S063
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-06-04
- Decision code
- APPR
- Date received
- 2025-03-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Centerpiece S. de. R.L. de C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada 11530, Tijuana, Baja California, 22250, Mexico for sterilization