PMA P930038S100
- Device
- ANGIO-SEAL VIP Vascular Closure Device
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S100
- Product code
- MGB
- Decision date
- 2022-08-26
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Replace a facility with an alternative facility that will conduct bioburden testing and sterility testing associated with routine dose audits.
Current openFDA PMA Record#
- Device
- ANGIO-SEAL VIP Vascular Closure Device
- Applicant
- Terumo Medical Corporation
- PMA number
- P930038
- Supplement
- S100
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-08-26
- Decision code
- OK30
- Date received
- 2022-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a facility with an alternative facility that will conduct bioburden testing and sterility testing associated with routine dose audits.