FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P060040
·
Supplement: S047
·
Decision Jan 11, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- PMA Number
- P060040
- Supplement Number
- S047
- 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
- January 11, 2016
- Date Received
- November 9, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR DESIGN MODIFICATIONS TO THE 14 V LITHIUM-ION BATTERY.
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 |