- Device
- Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S021
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2026-06-24
- Decision code
- APPR
- Date received
- 2026-04-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualify a new pre-cut soft tip tubing component from an alternate supplier