FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Artificial Heart
PMA: P030011
·
Supplement: S006
·
Decision Dec 23, 2009
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Artificial Heart
- Trade Name
- CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- PMA Number
- P030011
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- LOZ
- Generic Name
- Artificial heart
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 23, 2009
- Date Received
- November 23, 2009
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF A HEAT TREATMENT STEP.
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 |