PMA P080029
- Device
- QUICK-CLOSE VASCULAR SUTURING SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P080029
- Supplement
- S002
- Product code
- MGB
- Decision date
- 2014-12-18
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- CHANGE TO THE DIMENSIONAL TOLERANCES OF THE CANNULA AND MODIFICATIONS TO THE BONDING PROCESS FOR TWO DEVICE SUBASSEMBLIES.
Current openFDA PMA Record#
- Device
- QUICK-CLOSE VASCULAR SUTURING SYSTEM
- Applicant
- Cardiva Medical, Inc.
- PMA number
- P080029
- Supplement
- S002
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2014-12-18
- Decision code
- OK30
- Date received
- 2014-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE DIMENSIONAL TOLERANCES OF THE CANNULA AND MODIFICATIONS TO THE BONDING PROCESS FOR TWO DEVICE SUBASSEMBLIES.