PMA P930038S106
- Device
- Angio-Seal Vascular Closure Device
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S106
- Product code
- MGB
- Decision date
- 2025-08-07
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- a manufacturing change to the hemostasis cap component of the Insertion Sheath subassembly
Current openFDA PMA Record#
- Device
- Angio-Seal Vascular Closure Device
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S106
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2025-08-07
- Decision code
- OK30
- Date received
- 2025-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing change to the hemostasis cap component of the Insertion Sheath subassembly