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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP890003
Date Received01/05/1989
Decision Date08/24/1989
Product Code
NVZ[ Registered Establishments with NVZ ]
Docket Number 89M-0369
Notice Date 09/19/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the Synergyst™ II Models 7070 and 7071 Pulse Generators and the Model 9710 Programmer with the Model 9739A MemoryMod®. This device is indicated for cardiac pacing.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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S228 S229 S230 S231 S232 S233 S234 S235 S236 
S237 S238 S239 S240 S241 S242 S243 S245 S246 
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