PMA P200039S016

Device: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S016
Product code: QMG
Decision date: 2025-05-30
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: Re-ordering of manufacturing steps to further mitigate one of the already known catheter failure mode (sparking within the hub).

Current openFDA PMA Record#

Device: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S016
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2025-05-30
Decision code: OK30
Date received: 2025-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Re-ordering of manufacturing steps to further mitigate one of the already known catheter failure mode (sparking within the hub).