FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P870072
·
Decision Dec 20, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- PMA Number
- P870072
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 20, 1995
- Date Received
- November 24, 1987
- Expedited Review
- N
- Docket Number
- 97M-0136
Advisory Committee Statement
INTENDED AS A BRIDGE TO CARDIAC TRANSPLANTATION FOR USE IN PATIENTS SUFFERING FROM END-STAGE HEART FAILURE. THE PATIENT SHOULD MEET ALL OF THE FOLLOWING CRITERIA: 1)CANDIDATE FOR CARDIAC TRANSPLANTATION, 2) IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, AND 3) DEPENDENCE O N, OR INCOMPLETE RESPONSE TO, CONTINUE VASOPRESSOR SUPPORT
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 |