Device, Hemostasis, Vascular
Research PMA P120016 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- VASCADE MVP XL VVCS Model 800-1014XL
- PMA Number
- P120016
- Supplement Number
- S039
- 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
- March 27, 2026
- Date Received
- September 30, 2025
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 8 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs. The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is also indicated for enabling same day discharge in patients who have undergone catheter-based cardiac arrhythmia ablation procedures utilizing 8 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs.
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 |