PMA P930038S028
- Device
- ANGIO-SEAL VASCULAR CLOSURE DEVICE
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S028
- Product code
- MGB
- Decision date
- 2001-01-16
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- CHANGE FROM A MANUAL CRIMPING PROCEDURE TO AN AUTOMATED PNEUMATIC PROCESS TO SEAL THE CRIMP STOP ONTO THE SUTURE.
Current openFDA PMA Record#
- Device
- ANGIO-SEAL VASCULAR CLOSURE DEVICE
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S028
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2001-01-16
- Decision code
- OK30
- Date received
- 2000-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM A MANUAL CRIMPING PROCEDURE TO AN AUTOMATED PNEUMATIC PROCESS TO SEAL THE CRIMP STOP ONTO THE SUTURE.