| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR |
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| Generic Name | Pulse generator, permanent, implantable |
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| Applicant | MEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112 |
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| PMA Number | P930022 |
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| Date Received | 07/21/1993 |
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| Decision Date | 02/07/1997 |
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| Product Code |
NVZ |
| Docket Number | 97M-0121 |
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| Notice Date | 04/02/1997 |
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| Advisory Committee |
Cardiovascular |
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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 LEGEND PLUS(R) PACING SYSTEM INCLUDING THE LEGEND PLUS(R) PULSE GENERATOR MODELS 8446 AND 8448; THE MODEL 9790 AND 9790C PROGRAMMERS WITH THE MODEL 9891 BASELINE SOFTWARE AND WITH THE MODE 9807 SOFTWARE. THIS SYSTEM IS INDICATED FOR PERMANENT VENTRICULAR OR ATRIAL PACING APPLICATIONS. ITS USE IS INDICATED IN THE TREATMENT OF PATIENTS WHO MAY BENEFIT FROM A PCING RATE THAT CHAGNES IN RESPONSE TO ACTIVITY. VENTRICULAR INDICATIONS INCLUDE: 1)CHRONIC ATRIAL FLUTTER OR FIBRILLATION WITH SLOW VENTRICULAR RESPONSE; 2)SINUS NODE DYSFUNCTIONS OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, CHRONOTROPIC INSUFFICIENCY, ETC.,); AND 3)AV BLOCK. ATRIAL INDICATIONS INCLUDE:1)SINUS NODE DYSFUNCTION OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, ETC.,) WITH INTACT AV CONDUCTION |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 S019 |
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