Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
FDA premarket approval P200039/S011 · decided 2023-05-08
Approval details
- PMA number
- P200039
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2023-02-21
- Decision date
- 2023-05-08
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for updated labeling to include post approval study results.
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