FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Artificial Heart
PMA: P030011
·
Supplement: S057
·
Decision Dec 8, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Artificial Heart
- Trade Name
- SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System
- PMA Number
- P030011
- Supplement Number
- S057
- Device Class
- FDA Class 3
- Product Code
- LOZ
- Generic Name
- Artificial heart
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 8, 2017
- Date Received
- November 1, 2017
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to the labeling of the Companion 2 Driver System.
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 |
|---|---|---|---|
| LOZ | Artificial Heart | FDA class 3 | Unknown |