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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 NameCLOSER / CLOSER S 6 FRENCH SMC SYSTEMS
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS031
Date Received01/29/2001
Decision Date11/20/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the closer 6 fr. Systems during interventional catheterization (expanded indications for use) requiring 7 to 8 fr. Sheaths. The closer and the closer s 6 fr. Smc systems are modified, as indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 8 fr. Sheaths. The closer and the closer s 6 fr. Smc systems reduced the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations).
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