PMA P050007S010
- Device
- STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S010
- Product code
- MGB
- Decision date
- 2008-07-23
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL FOR LABELING ADDITIONS TO THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S010
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2008-07-23
- Decision code
- APPR
- Date received
- 2008-07-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING ADDITIONS TO THE INSTRUCTIONS FOR USE.