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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(R) II IMPLANT. PACEMAKER PULSE GENERATOR
Classification Namepulse-generator, single chamber, single
Generic Namesingle chamber, antitachycardia, pulse generator
ApplicantINTERMEDICS, INC.
PMA NumberP860007
Supplement NumberS005
Date Received12/20/1990
Decision Date07/02/1991
Product Code
LWW
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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