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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 NameVITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator programming software
Regulation Number870.3610
ApplicantVITATRON, INC.
PMA NumberP990001
Supplement NumberS017
Date Received02/18/2005
Decision Date03/16/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the vitatron c60 dr (model c60a3) and vitatron c20 sr (model c20a3) implantable pulse generators and their associated software (vsf11/vsf12 version 1. 0); and the t-series application software (vsf07/vsf08 version 1. 2); and cd-rom (vse03/vse04 version 2. 3).
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