PMA P050007S038
- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S038
- Product code
- MGB
- Decision date
- 2019-05-23
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Manufacturing move within an approved facility for the Prostar XL Percutaneous Vascular Surgical System and the StarClose SE Vascular Closure System.
Current openFDA PMA Record#
- Device
- StarClose SE Vascular Closure System
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S038
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-05-23
- Decision code
- OK30
- Date received
- 2019-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing move within an approved facility for the Prostar XL Percutaneous Vascular Surgical System and the StarClose SE Vascular Closure System.