RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
FDA premarket approval P040012/S008 · decided 2006-03-27
Approval details
- PMA number
- P040012
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2006-02-24
- Decision date
- 2006-03-27
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF A NEW CATHETER LEAK TEST TO THE MANUFACTURING PROCESS; 2) MODIFICATIONS TO THE RADIO FORCE IN-PROCESS TESTING PARAMETERS; 3) INCREASING THE STRINGENCY OF THE AQL FOR THE DISTAL JUNCTION TEST; 4) ADDITION OF A MICROSCOPIC VISUAL INSPECTION STEP TO DETECT BROKEN STRUTS; AND 5) ADDITION OF AN INSPECTION STEP TO VERIFY THAT THE ADHESIVE WAS CORRECTLY APPLIED AND COMPLETELY CURED.
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510(k) clearances by this applicant
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|---|---|---|
| NC TREK NEO Coronary Dilatation Catheter (K220634) | Abbott Vascular | 2022-06-30 |
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| HI-TORQUE TurnTrac Guide Wire Family (K173795) | Abbott Vascular | 2018-01-12 |