PMA P200039S018

Device: Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S018
Product code: QMG
Decision date: 2025-10-14
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: A change in the quality control incoming inspection process to implement a dock to stock program for select low-severity and low-risk components of the C2 / C2+ / C2 Aero coronary IVL catheters.

Current openFDA PMA Record#

Device: Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S018
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2025-10-14
Decision code: OK30
Date received: 2025-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: A change in the quality control incoming inspection process to implement a dock to stock program for select low-severity and low-risk components of the C2 / C2+ / C2 Aero coronary IVL catheters.