Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S028 |
Date Received | 11/15/2002 |
Decision Date | 12/06/2002 |
Product Codes |
DTB DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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