PMA P930038S097
- Device
- Angio-Seal Vascular Closure Devices
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S097
- Product code
- MGB
- Decision date
- 2019-12-13
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Transfer of the Gearbox Assembly Machine for ANGIO-SEAL Evolution devices from Abbott to Terumo Puerto Rico (TPR).
Current openFDA PMA Record#
- Device
- Angio-Seal Vascular Closure Devices
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S097
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-12-13
- Decision code
- OK30
- Date received
- 2019-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the Gearbox Assembly Machine for ANGIO-SEAL Evolution devices from Abbott to Terumo Puerto Rico (TPR).