Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators
FDA premarket approval P200039/S017 · decided 2025-06-27
Approval details
- PMA number
- P200039
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2025-05-08
- Decision date
- 2025-06-27
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- approval for three changes in the generator portion of the device: an alternate relay, alternate 14.4V battery, and revisions to Shockwave IVL 825 series generator Operator Manual associated with the alternate battery change
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