Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
FDA premarket approval P200039/S004 · decided 2022-01-04
Approval details
- PMA number
- P200039
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2021-10-22
- Decision date
- 2022-01-04
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for use of the 1-wire printed circuit board in the catheter connector.
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