PMA P200039S006
- Device
- Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S006
- Product code
- QMG
- Decision date
- 2022-03-23
- Generic name
- Shockwave intravascular lithotripsy system
- Approval order statement
- Approval for minor design, software, and labeling modifications to the device.
Current openFDA PMA Record#
- Device
- Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S006
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2022-03-23
- Decision code
- APPR
- Date received
- 2021-12-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design, software, and labeling modifications to the device.