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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 NameAFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemaker programmer and base station
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS050
Date Received07/30/1998
Decision Date01/22/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the affinity dr model 5330 l/r dual-chamber and affinity sr model 5130 l/r single-chamber rate-adaptive pulse generators with autocapture. The devices, as modified, will be marketed under the trade affinity dr model 5330 l/r and affinity sr model 5130 l/r and are indicated for rate-adaptive support pacing.
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