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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
PMA NumberP960043
Supplement NumberS009
Date Received07/21/1998
Decision Date05/05/1999
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for additional effectiveness claims (i.e., reduced time to ambulation and reduced time to discharge) for the Techstar(R) XL 6 Fr. Percutaneous Vascular Surgical (PVS) System. The device will be marketed under the trade name Techstar XL 6F Percutaneous Vascular Surgical (PVS) System and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to ambulation (patient walks ten feet) of patients who have undergone diagnostic catheterization procedures using 5 Fr. to 6 Fr. sheaths. The Techstar XL 6 Fr. PVS System reduces the time to discharge in patients having undegone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations)."
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