PMA P120016S028
- Device
- VASCADE MVP VVCS
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S028
- Product code
- MGB
- Decision date
- 2021-08-06
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for the expansion of the indication for the VASCADE MVP Venous Vascular Closure System to include same day discharge in addition to existing claims.
Current openFDA PMA Record#
- Device
- VASCADE MVP VVCS
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S028
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-08-06
- Decision code
- APPR
- Date received
- 2021-02-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the expansion of the indication for the VASCADE MVP Venous Vascular Closure System to include same day discharge in addition to existing claims.