- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter; Sh
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S022
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2026-05-07
- Decision code
- OK30
- Date received
- 2026-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the Shockwave C2/C2+ Coronary IVL Catheter’s coated balloon subassembly in-process inspection acceptance criteria for cumulative coating voids at the supplier