- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S005
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2023-08-17
- Decision code
- APPR
- Date received
- 2021-11-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of an alternate supplier for the Shockwave C2 Coronary IVL Catheter hypotube.