PMA P930038S083
- Device
- Angio Seal Vascular Closure Device
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S083
- Product code
- MGB
- Decision date
- 2017-05-19
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to implement alternate automated inspection equipment for the AngioSeal puncture locator component.
Current openFDA PMA Record#
- Device
- Angio Seal Vascular Closure Device
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S083
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2017-05-19
- Decision code
- APPR
- Date received
- 2016-11-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement alternate automated inspection equipment for the AngioSeal puncture locator component.