PMA P120016S043
- Device
- VASCADE 5F Vascular Closure System
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S043
- Product code
- MGB
- Decision date
- 2026-09-10
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- an additional supplier for the collagen plug component of the VASCADE 5F (Model 700-500DX)
Current openFDA PMA Record#
- Device
- VASCADE 5F Vascular Closure System
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S043
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-09-10
- Decision code
- OK30
- Date received
- 2026-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier for the collagen plug component of the VASCADE 5F (Model 700-500DX)