STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA premarket approval P050007/S006 · decided 2007-07-30
Approval details
- PMA number
- P050007
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular Devices
- Date received
- 2007-05-07
- Decision date
- 2007-07-30
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE PUSHER BODY FOR BOTH THE STARCLOSE? VASCULAR CLOSURE SYSTEM (VCS) AND THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM AD FOR THE ADDITION OF CHAMBERS ON THE INTERIOR OF THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM TO IMPROVE THE RETRACTION OF THE THUMB ADVANCER.
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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 |