- Device
- Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S004
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2022-01-04
- Decision code
- APPR
- Date received
- 2021-10-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of the 1-wire printed circuit board in the catheter connector.