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. |
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Device | VITATRON(R) DEMA PACING SYSTEM |
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 | P990001 |
Supplement Number | S004 |
Date Received | 05/17/2000 |
Decision Date | 11/13/2000 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DEMA PACING SYSTEM AND THE CITATRON APPLICATION SOFTWARE MODEL VSA02, VERSION 6. THE DEMA PACING SYSTEM CONSISTS OF THE FOLLOWING PULSE GENERATORS: CLARITY DDR MODELS 860, 862, 865; CLARITY SSIR MODELS 560, 562, 565; DIAMOND 3 MODEL 840; RUBY 3 MODEL 740; TOPAZ 3 MODEL 540; JADE 3 MODEL 340; VITA 2 DDR MODEL 830; VITA 2 MODEL 530. |
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