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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 NamePROSTAR XL 8 AND 10 FRENCH, CLOSER, CLOSER S, PERCLOSE AT, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS047
Date Received07/22/2003
Decision Date09/02/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add wording in the precautions section in the labeling, informing the user that reaccess/ repuncture of the femoral artery with the above listed devices is not restricted for patients who have previously received these devices in earlier arteriotomy repairs.
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