PMA P050007S015
- Device
- STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S015
- Product code
- MGB
- Decision date
- 2009-11-13
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL TO CHANGE TWO MANUALLY PERFORMED OPERATIONS TO SEMI-AUTOMATED OPERATIONS AND THE REMOVAL OF AN IN-PROCESS INSPECTION.
Current openFDA PMA Record#
- Device
- STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S015
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2009-11-13
- Decision code
- APPR
- Date received
- 2009-06-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE TWO MANUALLY PERFORMED OPERATIONS TO SEMI-AUTOMATED OPERATIONS AND THE REMOVAL OF AN IN-PROCESS INSPECTION.