- Device
- StarClose SE Vascular Surgical System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S046
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2025-03-09
- Decision code
- APPR
- Date received
- 2024-10-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Isomedix Operations, Inc., 43425 Business Park Drive, Temecula, CA 92590 for sterilization