PMA P200039S011
- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S011
- Product code
- QMG
- Decision date
- 2023-05-08
- Classification
- Cardiovascular
- Generic name
- Shockwave intravascular lithotripsy system
- Approval order statement
- Approval for updated labeling to include post approval study results.
Current openFDA PMA Record#
- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S011
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2023-05-08
- Decision code
- APPR
- Date received
- 2023-02-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include post approval study results.