PMA P220003S022

Device: PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S022
Product code: NKM
Decision date: 2025-06-04
Classification: Cardiovascular
Generic name: Mitral valve repair devices
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

Current openFDA PMA Record#

Device: PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S022
Product code: NKM
Generic name: Mitral valve repair devices
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