| 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 | MICRONY PACEMAKERS |
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| Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
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| Applicant | Abbott Medical
15900 Valley View Court
Sylmar, CA 91335 |
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| PMA Number | P970013 |
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| Date Received | 01/03/1997 |
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| Decision Date | 12/21/2000 |
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| Product Code |
LWO |
| Docket Number | 01M-0013 |
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| Notice Date | 01/16/2001 |
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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 MICRONY(TM) SR+ MODEL 2425T SINGLE CHAMBER RATE ADAPTIVE PULSE GENERATOR, WHICH IS PROGRAMMED WITH THE APS II PROGRAMMER WITH MODLE 3204A SOFTWARE, THE APSU PROGRAMMER, AND THE MODEL 3500/3510 PROGRAMMER WITH MODEL 3304 SOFTWARE. THE DEIVCE IS INDICATED FOR THE FOLLOWING: 1) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHY-ARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. 2) ATRIAL PACING IN PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS. 3) VENTRICULAR PACING IN PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST REQUIRING SHORT PERIODS OF PACING SUPPORT, CHRONIC ATRIAL FIBRILLATION, AND SEVERE PHYSICAL DISABILITY. 4) RATE-MODULATED PACING IN PATIENTS WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036
S037 S038 S039 S040 S041 S042 S043 S044 S045 S047 S048 S049
S050 S051 S052 S054 S055 S056 S057 S058 S059 S060 S063 S064
S065 S066 S067 S069 S070 S071 S072 S073 S074 S075 S076 S077
S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 S089
S090 S091 S092 S093 |
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