STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS
FDA premarket approval P050007/S009 · decided 2008-08-25
Approval details
- PMA number
- P050007
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular Devices
- Date received
- 2008-03-31
- Decision date
- 2008-08-25
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE INDICATED FOR THE FOLLOWING: THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR USE TO ALLOW PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERI
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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 |