FDA.reportPublic FDA data

PMA P950037S028

Device
PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
Applicant
Biotronik, Inc.
PMA number
P950037
Supplement
S028
Product code
DXY
Decision date
2002-12-06
Classification
Implantable Pacemaker Pulse-generator
Generic name
implantable pacemaker Pulse-generator
Approval order statement
APPROVAL FOR 1) THE COMBINATION OF ALL THE FEATURES OF THE PHILOS FAMILY WITH THE CLOSED LOOP STIMULATION (CLS METHOD OF RATE ADAPTIVE PACING; AND 2) THE ADDITION OF THE PROTOS APPLICATION TO THE SWM AND ATA PROGRAMMER SOFTWARE CARTRIDGES, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROTOS VR AND PROTOS DR; AND SOFTWARE CARTRIDGES B-K00.P.U AND A-K00.0.U, AND IS INDICATED FOR: A) RATE ADAPTIVE PACING WITH THE PROTOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. B) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD-DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. C) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.

Current openFDA PMA Record#

Device
PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
Applicant
Biotronik, Inc.
PMA number
P950037
Supplement
S028
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
2002-12-06
Decision code
APPR
Date received
2002-11-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR 1) THE COMBINATION OF ALL THE FEATURES OF THE PHILOS FAMILY WITH THE CLOSED LOOP STIMULATION (CLS METHOD OF RATE ADAPTIVE PACING; AND 2) THE ADDITION OF THE PROTOS APPLICATION TO THE SWM AND ATA PROGRAMMER SOFTWARE CARTRIDGES, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROTOS VR AND PROTOS DR; AND SOFTWARE CARTRIDGES B-K00.P.U AND A-K00.0.U, AND IS INDICATED FOR: A) RATE ADAPTIVE PACING WITH THE PROTOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. B) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD-DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. C) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.