PMA P200039S013

Device: Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S013
Product code: QMG
Decision date: 2024-10-24
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: a new Shockwave Medical catheter manufacturing site located at SWAV CR SRL Coyol Free Zone, Building B50.B., El Coyol, Alajuela, Costa Rica and a new Steris AST sterilization facility located at Coyol Free Zone, Building B16, Alajuela, Costa Rica.

Current openFDA PMA Record#

Device: Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S013
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2024-10-24
Decision code: APPR
Date received: 2024-02-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a new Shockwave Medical catheter manufacturing site located at SWAV CR SRL Coyol Free Zone, Building B50.B., El Coyol, Alajuela, Costa Rica and a new Steris AST sterilization facility located at Coyol Free Zone, Building B16, Alajuela, Costa Rica.