PMA P120016S021
- Device
- VASCADE VASCULAR CLOSURE SYSTEM (VCS)
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S021
- Product code
- MGB
- Decision date
- 2018-03-30
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to expand the indication of the VASCADE VCS to include femoral venous access site closure.
Current openFDA PMA Record#
- Device
- VASCADE VASCULAR CLOSURE SYSTEM (VCS)
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S021
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-03-30
- Decision code
- APPR
- Date received
- 2016-11-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to expand the indication of the VASCADE VCS to include femoral venous access site closure.