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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 NameINTERTACH II MODELS 262-16
Classification Namepulse-generator, single chamber, single
Generic Namesingle chamber, antitachycardia, pulse generator,pacemaker, implantable
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP860007
Supplement NumberS020
Date Received05/19/1998
Decision Date07/06/1998
Product Code
LWW
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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