PMA P120016S019
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S019
- Product code
- MGB
- Decision date
- 2016-02-10
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Relocation of the Key Fusing subassembly to the manufacturing facility in Guayamas, Sonora, Mexico.
Current openFDA PMA Record#
- Device
- VASCADE VASCULAR CLOSURE SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P120016
- Supplement
- S019
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-02-10
- Decision code
- OK30
- Date received
- 2016-01-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the Key Fusing subassembly to the manufacturing facility in Guayamas, Sonora, Mexico.