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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS006
Date Received02/27/2002
Decision Date03/13/2002
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic/vitatron carelink programmer model 2090, model 2067 carelink programmer rf head, model 2290 lead analyzer, model 2292 analyzer cable, model 2091 carelink programmer modem, model 8190 software for the model 2290 lead analyzer, model 5437a programmer interface cable, model 2090 ec ecg cable, model 2090 ab cable, model 2090 tps touchpen, model 2090 rv remote view software, model 9964 carelink programmer software for the gem ii dr icd (model 7273), model 9966 carelink programmer software for the marquis dr icd, model 9896 carelink programmer software for the jewel (model 7218), and vitatron model vsc02 version 6. 1 carelink programmer software. In addition, this submission includes the following programmer software applications (previously approved for other medtronic, vitatron, or cpi programmers) that have been modified for use with the model 2090 carelink programmer: vitatron provit model vsa02 v6. 1, kappa 400 (9952/a), kappa 600/700 (9953/a), kappa 800/900 (9988), sigma (9963/a), insync (9980), reveal plus (9809), analyzer (8190), gem (9962), gem dr (9960), gem ii vr (9965), gem ii dr (9964), gem iii vr (9971), gem iii dr (9970), gem iii at (9974), baseline 7 (9891/a), cpi prelude (9892), cpi triumph (9892), jewel pcd (9895), jewel cd (9895), jewel af (9961), jewel plus (9895), pcd (9895), preva d, st-dr (9959, jewel (9894), jewel ii (9955). The device, as modified, will be marketed under the trade name medtronic/ vitatron carelink programmer model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
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