Shockwave lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter
FDA premarket approval P200039/S018 · decided 2025-10-14
Approval details
- PMA number
- P200039
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Shockwave lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2025-09-15
- Decision date
- 2025-10-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- A change in the quality control incoming inspection process to implement a dock to stock program for select low-severity and low-risk components of the C2 / C2+ / C2 Aero coronary IVL catheters.
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