PMA P120016S001
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S001
- Product code
- MGB
- Decision date
- 2014-04-30
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- ELIMINATE POST-STERILIZATION INSPECTION STEPS AND ADD SUBASSEMBLY QUALITY CONTROL INSPECTION STEPS TO SUBASSEMBLIES.
Current openFDA PMA Record#
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S001
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2014-04-30
- Decision code
- OK30
- Date received
- 2014-03-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATE POST-STERILIZATION INSPECTION STEPS AND ADD SUBASSEMBLY QUALITY CONTROL INSPECTION STEPS TO SUBASSEMBLIES.