PMA P200039S025

Device: SHOCKWAVE™ INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH SHOCKWAVE C2/C2+ CORONARY IVL CATHETER
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S025
Product code: QMG
Decision date: 2026-09-11
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: a raw material impurity profile change (for the hydrophilic coating) at a supplier

Current openFDA PMA Record#

Device: SHOCKWAVE™ INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH SHOCKWAVE C2/C2+ CORONARY IVL CATHETER
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S025
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2026-09-11
Decision code: OK30
Date received: 2026-08-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a raw material impurity profile change (for the hydrophilic coating) at a supplier