PMA P050007S042
- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S042
- Product code
- MGB
- Decision date
- 2022-12-16
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Implementation of a sustainable ethylene oxide (SEO) sterilization cycle ("soft" cycle) at the Synergy Health Ireland facility.
Current openFDA PMA Record#
- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S042
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-12-16
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a sustainable ethylene oxide (SEO) sterilization cycle ("soft" cycle) at the Synergy Health Ireland facility.