FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Scaffold, Dissection Repair
PMA: P180034
·
Supplement: S001
·
Decision Jan 28, 2020
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
- S001
- 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
- January 28, 2020
- Date Received
- August 2, 2019
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the Tack Endovascular System® (6F, 4.0-8.0mm) for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s).
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 |