PMA P050007S023
- Device
- STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S023
- Product code
- MGB
- Decision date
- 2010-01-27
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL TO INCREASE THE CLEARANCE OF THE CLIP DELIVERY TUBE AND MINOR MODIFICATIONS TO THE EXCHANGE SYSTEM AND SHEATH SPLITTER FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S023
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2010-01-27
- Decision code
- APPR
- Date received
- 2009-11-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO INCREASE THE CLEARANCE OF THE CLIP DELIVERY TUBE AND MINOR MODIFICATIONS TO THE EXCHANGE SYSTEM AND SHEATH SPLITTER FOR THE DEVICE.