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Device | THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S030 |
Date Received | 12/26/2000 |
Decision Date | 02/02/2001 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE MULTI-LUMEN STRUCTURE OF THE SHEATH (FROM 5 LUMENS TO 3 LUMENS), AS WELL AS COMBINING THE EXIT RAMP AND PEBAX BEADING INTO A SINGLE INJECTION MOLDED PEBAX COMPONENT TO SIMPLIFY THE MANUFACTURING PROCESS. THESE MODIFICATIONS APPLY TO BOTH THE CLOSER 6 FR. SMC SYSTEM AND THE CLOSER S 6 FR. SMC SYSTEM. |