- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S002
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2021-06-04
- Decision code
- APPR
- Date received
- 2021-03-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the revised protocol for the post-approval study (PAS) protocol.