PMA P120016S017
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S017
- Product code
- MGB
- Decision date
- 2016-03-24
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for the implementation of additional equipment used to manufacture the key fusing subassembly.
Current openFDA PMA Record#
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S017
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-03-24
- Decision code
- APPR
- Date received
- 2015-11-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of additional equipment used to manufacture the key fusing subassembly.