PMA P120016S030
- Device
- Cardiva VASCADE Family
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S030
- Product code
- MGB
- Decision date
- 2022-11-08
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Alternative to batch testing for bacterial endotoxins.
Current openFDA PMA Record#
- Device
- Cardiva VASCADE Family
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S030
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-11-08
- Decision code
- OK30
- Date received
- 2022-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative to batch testing for bacterial endotoxins.