FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Scaffold, Dissection Repair
PMA: P180034
·
Supplement: S005
·
Decision Sep 7, 2021
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Scaffold, Dissection Repair
- Trade Name
- Tack Endovascular System (6F)
- PMA Number
- P180034
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- QCT
- Generic Name
- Scaffold, dissection repair
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 7, 2021
- Date Received
- June 10, 2021
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for the labeling updates which incorporate the final 36-month results from the TOBA II Post Approval Study.
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 |
|---|---|---|---|
| QCT | Scaffold, Dissection Repair | FDA class 3 | Unknown |