Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
FDA premarket approval P200039/S013 · decided 2024-10-24
Approval details
- PMA number
- P200039
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2024-02-07
- Decision date
- 2024-10-24
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- a new Shockwave Medical catheter manufacturing site located at SWAV CR SRL Coyol Free Zone, Building B50.B., El Coyol, Alajuela, Costa Rica and a new Steris AST sterilization facility located at Coyol Free Zone, Building B16, Alajuela, Costa Rica.
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