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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.
 
DeviceVASOSEAL (TM)
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E. County Rd. B E.
St Paul, MN 55117
PMA NumberP920004
Supplement NumberS006
Date Received02/25/1997
Decision Date04/15/1997
Withdrawal Date12/06/2013
Product Code MGB 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE INDICATIONS FOR USE TO INCLUDE SUE OF VASOSEAL(R) FOLLOWING STENT IMPLANTATION. THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE IS NOW INDICATED FOR USE IN REDUCING TIEM TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY, BALLOON ANGIOPLASTY OR STENT PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL(R) VHD IS ALSO INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS IN BALLOON ANGIOPLASTY AND STENT PATIENTS WHEN IMMEDIATE SHEALTH REMOVAL IS DESIRED. HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.
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