PMA P050007S001
- Device
- STARCLOSE VASCULAR CLOSURE SYSTEM
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S001
- Product code
- MGB
- Decision date
- 2007-02-02
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS:THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050007S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STARCLOSE VASCULAR CLOSURE SYSTEM
- Applicant
- Abbott Vascular Devices
- PMA number
- P050007
- Supplement
- S001
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2007-02-02
- Decision code
- APPR
- Date received
- 2005-12-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS:THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.