PMA P120016S020
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S020
- Product code
- MGB
- Decision date
- 2016-08-01
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for a change to the material of the Joiner component of the VASCADE 6/7F Sleeve with Grip subassembly.
Current openFDA PMA Record#
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S020
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-08-01
- Decision code
- APPR
- Date received
- 2016-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the material of the Joiner component of the VASCADE 6/7F Sleeve with Grip subassembly.