FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Scaffold, Dissection Repair
PMA: P180034
·
Supplement: S002
·
Decision Apr 15, 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
- S002
- Device Class
- FDA Class 3
- Product Code
- QCT
- Generic Name
- Scaffold, dissection repair
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 15, 2020
- Date Received
- March 17, 2020
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Transfer of tube cutting processes to a new site.
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 |