| 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 | MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE |
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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 | S054 |
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| Date Received | 04/03/1998 |
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| Decision Date | 09/24/1998 |
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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 the Medtronic "The Analyzer" Lead Analysis dEvice Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 Software. "The Analyzer" is attached to the Medtronic Model 9790 Programmer (approved as P890003/S027) and the Model 8190 Software is installed onto the hard dirve of this Programmer. The device will be marketed under the trade name "Medtronic THE ANALYZER(TM) Lead Analysis Device Model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting. |
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