PMA P930038S091
- Device
- Angio-Seal Vascular Closure Devices
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S091
- Product code
- MGB
- Decision date
- 2019-03-06
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Transfer the bypass tube coating process to the Terumo Caguas, Puerto Rico facility.
Current openFDA PMA Record#
- Device
- Angio-Seal Vascular Closure Devices
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S091
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-03-06
- Decision code
- OK30
- Date received
- 2019-01-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer the bypass tube coating process to the Terumo Caguas, Puerto Rico facility.