FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shockwave Intravascular Lithotripsy System
PMA: P200039
·
Supplement: S001
·
Decision Apr 9, 2021
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Shockwave Intravascular Lithotripsy System
- Trade Name
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- PMA Number
- P200039
- Supplement Number
- S001
- 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
- April 9, 2021
- Date Received
- March 10, 2021
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval for transition to continued follow up study.
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 |