PMA P930038S081
- Device
- ANGIO SEAL VASCULAR CLOSURE DEVICE
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S081
- Product code
- MGB
- Decision date
- 2016-05-06
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Move the Carrier Tube component manufacturing to the existing Puerto Rico facility and automate the Carrier Tube manufacturing process.
Current openFDA PMA Record#
- Device
- ANGIO SEAL VASCULAR CLOSURE DEVICE
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S081
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-05-06
- Decision code
- OK30
- Date received
- 2016-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the Carrier Tube component manufacturing to the existing Puerto Rico facility and automate the Carrier Tube manufacturing process.