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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.
 
DeviceATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS010
Date Received07/22/2002
Decision Date08/30/2002
Product Codes DTA DTE KRG LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PCMCIA SOFTWARE CARTRIDGE INCLUDING AN INCREASE IN MEMORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) AND IS INTENDED TO ALLOW INTERROGATION AND PROGRAMMING OF BIOTRONIK ICD'S AND PACEMAKERS.
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