FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shockwave Intravascular Lithotripsy System
PMA: P200039
·
Supplement: S010
·
Decision Mar 22, 2023
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Shockwave Intravascular Lithotripsy System
- Trade Name
- Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters
- PMA Number
- P200039
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- QMG
- Generic Name
- Shockwave intravascular lithotripsy system
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 22, 2023
- Date Received
- December 27, 2022
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the addition of an alternate Field Programmable Gate Array (FPGA) component and minor Control Logic Board (CLB) design modifications.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QMG | Shockwave Intravascular Lithotripsy System | FDA class 3 | Unknown |