Approval Order Statement
APPROVAL FOR YOUR PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE:GUIDANT PULSAR MODELS 470, 970, 972, 1172, 1272 PULSE GENERATORS, GUIDANT PULSAR MAX MODELS 1170, 1171, 1270 PULSE GENERATORS, AND GUIDANT CONSULT (MODEL 2890) SOFTWARE.GUIDANT PULSAR/PULSAR MAX SERIES PACEMAKERS ARE INDICATED FOR THE FOLLOWING: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND. OR THIRD-DEGREE AV BLOCK SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCKSYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS (EG, SINUS BRADYCARDIA, SINUS ARREST, SINOATRIAL [SA] BLOCK) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS NEUROVASCULAR (VASOVAGAL) SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES ADAPTIVE-RATE PACING IS INDICATED FOR PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR LEVEL OF PHYSICAL ACTIVITY. THE PULSAR¿/PULSAR MAX¿ SERIES PACEMAKERS' DUAL CHAMBER AND ATRIAL TRACKING MODES ARE ALSO INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF THE FOLLOWING:CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF AV SYNCHRONY, INCLUDING VARYING DEGREES OF AV BLOCK VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM LOW CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE SECONDARY TO BRADYCARDIA. |
