| 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 | INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE |
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| Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
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| Applicant | MEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112 |
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| PMA Number | P010015 |
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| Supplement Number | S005 |
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| Date Received | 03/04/2002 |
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| Decision Date | 02/25/2003 |
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| Product Code |
LWP |
| 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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Approval Order Statement
APPROVAL FOR THE INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE WHICH IS INDICATED AS FOLLOWS: THE INSYNC III MODEL 8042 DEVICE IS INDICATED FOR THE REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III OR IV), IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35%, AND A QRS >=130 MS. RATE ADAPTIVE PACING IS PROVIDED FOR THOSE PATIENTS DEVELOPING A BRADYCARDIA INDICATION WHO MIGHT BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASE IN ACTIVITY. DUAL CHAMBER AND ATRIAL TRACKING MODES ARE INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. |
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