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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.
 
DeviceOPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP950029
Supplement NumberS003
Date Received09/10/1998
Decision Date11/18/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France.
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