Microny Pacemakers
FDA premarket approval P970013 · Pulse-generator, single chamber, sensor driven, implantable
Approval
- Applicant
- Abbott Medical
- Received
- January 3, 1997
- Decision date
- December 21, 2000 (APPR)
- Supplements
- 94, latest July 21, 2026
- Product code
- LWO – Pulse-Generator, Single Chamber, Sensor Driven, Implantable
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.