FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P060040
·
Supplement: S060
·
Decision Sep 29, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- PMA Number
- P060040
- Supplement Number
- S060
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 29, 2016
- Date Received
- July 1, 2016
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for mechanical and marking modifications to the System Controller and Percutaneous Cable.
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 |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | FDA class 3 | Unknown |