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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.
 
DeviceINTERTACH II MODELS 262-16
Generic NamePULSE-GENERATOR, SINGLE CHAMBER, SINGLE
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP860007
Supplement NumberS020
Date Received05/19/1998
Decision Date07/06/1998
Withdrawal Date 07/19/2012
Product Code LWW 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intetach II, Model 262-16 pulse generator.
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