FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Scaffold, Dissection Repair
PMA: P190027
·
Supplement: S003
·
Decision Sep 29, 2022
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Scaffold, Dissection Repair
- Trade Name
- Tack Endovascular System (4F)
- PMA Number
- P190027
- Supplement Number
- S003
- 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 29, 2022
- Date Received
- January 11, 2022
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for an alternate supplier for the delivery system.
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 |