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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.
 
DeviceORCHESTRA PROGRAMMER
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP980049
Supplement NumberS010
Date Received09/11/2003
Decision Date10/14/2003
Product Code MRM 
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 PROGRAMMING HEAD OF THE ORCHESTRA PROGRAMMER, INCLUDING THE ADDITION OF HIGH-SPEED TELEMETRY AND OTHER CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CPR3 PROGRAMMING HEAD AND IS INDICATED FOR USE WITH THE ORCHESTRA DEDICATED PROGRAMMER TO INTERROGATE AND PROGRAM ELA MEDICAL PULSE GENERATORS VIA BI-DIRECTIONAL TELEMETRY.
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