PMA P120016S016
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S016
- Product code
- MGB
- Decision date
- 2015-07-29
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL FOR A LABELING CHANGE FOR THE IMPLEMENTATION OF AN ALTERNATIVE TECHNIQUE FOR RELEASE OF COLLAGEN FROM THE VASCADE DEVICE.
Current openFDA PMA Record#
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S016
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2015-07-29
- Decision code
- APPR
- Date received
- 2015-06-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE FOR THE IMPLEMENTATION OF AN ALTERNATIVE TECHNIQUE FOR RELEASE OF COLLAGEN FROM THE VASCADE DEVICE.