FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Device, Hemostasis, Vascular
PMA: P120016
·
Supplement: S040
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- Cardiva, VASCADE Family
- PMA Number
- P120016
- Supplement Number
- S040
- Device Class
- FDA Class 3
- Product Code
- MGB
- Generic Name
- Device, hemostasis, vascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 23, 2026
- Date Received
- December 30, 2025
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an additional supplier for the collagen plug component of the VASCADE 6/7F (Model 700-580I) and VASCADE MVP Venous Vascular Closure System (VVCS) (Model 800-612C) devices
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 |
|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | FDA class 3 | Unknown |