STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA premarket approval P050007/S004 · decided 2007-03-23
Approval details
- PMA number
- P050007
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular Devices
- Date received
- 2006-10-24
- Decision date
- 2007-03-23
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR DESIGN CHANGES T THE STARCLOSE VASCULAR CLOSURE SYSTEM (VCS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARCLOSE SE VASCULAR CLOSURE SYSTEM AND 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 AND FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (K052454) | Abbott Vascular Devices | 2005-09-14 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |