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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS050
Date Received07/30/1998
Decision Date01/22/1999
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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