PMA P120016S024
- Device
- VASCADE MVP Venous Vascular Closure System (VVCS)
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S024
- Product code
- MGB
- Decision date
- 2018-11-27
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for 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 6-12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120016S024B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VASCADE MVP Venous Vascular Closure System (VVCS)
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S024
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-11-27
- Decision code
- APPR
- Date received
- 2018-05-30
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for 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 6-12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.