FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Shockwave Intravascular Lithotripsy System
PMA: P200039
·
Supplement: S003
·
Decision Jul 22, 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 IVL Catheter
- PMA Number
- P200039
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- QMG
- Generic Name
- Shockwave intravascular lithotripsy system
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- July 22, 2021
- Date Received
- July 1, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
New class 8 cleanroom.
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 |