Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter
FDA premarket approval P200039/S003 · decided 2021-07-22
Approval details
- PMA number
- P200039
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter
- Generic name
- Shockwave intravascular lithotripsy system
- Applicant
- Shockwave Medical, Inc.
- Date received
- 2021-07-01
- Decision date
- 2021-07-22
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- QMG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- New class 8 cleanroom.
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