STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA premarket approval P050007/S023 · decided 2010-01-27
Approval details
- PMA number
- P050007
- Supplement
- S023
- 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
- 2009-11-02
- Decision date
- 2010-01-27
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL TO INCREASE THE CLEARANCE OF THE CLIP DELIVERY TUBE AND MINOR MODIFICATIONS TO THE EXCHANGE SYSTEM AND SHEATH SPLITTER FOR THE DEVICE.
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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 |