Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac
FDA premarket approval P200039/S009 · decided 2023-02-02
Approval details
- PMA number
- P200039
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2022-12-08
- Decision date
- 2023-02-02
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for updated labeling to include the final results of your continued follow up study.
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