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Device | AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S041 |
Date Received | 01/27/2005 |
Decision Date | 06/20/2005 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD THE ENRHYTHM MODEL P1501DR TO THE POST-APPROVAL STUDY OF THE DEVICE. |