FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Artificial Heart
PMA: P030011
·
Supplement: S016
·
Decision Aug 20, 2012
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Artificial Heart
- Trade Name
- SYNCARDIA COMPANION 2 DRIVER SYSTEM
- PMA Number
- P030011
- Supplement Number
- S016
- 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
- August 20, 2012
- Date Received
- June 21, 2012
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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 |