PMA P120016S025
- Device
- Cardiva VASCADE VCS
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S025
- Product code
- MGB
- Decision date
- 2018-10-02
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to modify the key sub-assembly design for the 5F and 6/7F devices.
Current openFDA PMA Record#
- Device
- Cardiva VASCADE VCS
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S025
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-10-02
- Decision code
- APPR
- Date received
- 2018-07-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the key sub-assembly design for the 5F and 6/7F devices.