| 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 | MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS |
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| Generic Name | implantable pacemaker Pulse-generator |
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| Regulation Number | 870.3610 |
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| Applicant | Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112 |
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| PMA Number | P890003 |
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| Supplement Number | S043 |
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| Date Received | 02/09/1996 |
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| Decision Date | 07/01/1996 |
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| Product Code |
DXY |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR MARKETING OF A SUBSET OF PULSE GENERATROS FROM THE APPROVED THERA-I/PRODIGY HARDWARE AND SOFTWARE PLATFORMS. THE DEVICES AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:MEDTRONIC:THERA MODEL 7968I PULSE GENERATOR; PRODIGY MODEL 8158 PULSE GENERATOR; PREVA MODELS 7088, 7089, 8088, AND 8089 PULSE GENERATORS; MODELS 9898E AND 9899E SOFTWARE - VITATRON:LEGACY II MODELS 126/128/526/528/726/728/826/828 PULSE GENERATORS; VISA MODELS 115/116/415/416/425/426/435/436 PULSE GENERATORS; AND MODEL 9849E SOFTWARE |
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