- Device
- Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S020
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2026-03-05
- Decision code
- OK30
- Date received
- 2026-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing and quality control improvements to the catheter lamination process and operating parameters, adhesive tolerances, and related in-process inspections