- Device
- Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S009
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2023-02-02
- Decision code
- APPR
- Date received
- 2022-12-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include the final results of your continued follow up study.