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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS030
Date Received12/26/2000
Decision Date02/02/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
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.
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