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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 NameCOSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS021
Date Received02/19/1998
Decision Date05/21/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following pacemakers which incorporate the edgebadn design: cosmos 3 model 284-09e; cosmos ii model 284-05e; stride model 294-05e; dash model 292-03e; dart model 292-05e; unity model 292-07e; nova iii model 282-07e; and the quantum iii model 254-27e. Supplement is approved for the use of an alternate packaging of polyethylene terephthalate glycol (petg) for all the edgeband models listed above and the folowing additional models: the side-lock(tm) implantable pulse generator models 282-07, 254-27, and 254-31, and the nova ii model 281-05 and nova iii model 282-04 pulse generators.
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