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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 MODELS 262-16/262-16R DISCON.TEST
Classification Namepulse-generator, single chamber, single
Generic Namesingle chamber, antitachycardia, pulse generator
ApplicantINTERMEDICS, INC.
PMA NumberP860007
Supplement NumberS010
Date Received07/10/1992
Decision Date01/11/1993
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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