| 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. |
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| Trade Name | REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS |
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| Classification Name | pulse generator, external pacemaker, dual-chamber |
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| Generic Name | implantable pacemaker pulse generator,pacemaker programmer |
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| Regulation Number | 870.3600 |
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| Applicant | BIOTRONIK, INC. |
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| PMA Number | P950037 |
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| Supplement Number | S084 |
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| Date Received | 07/15/2010 |
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| Decision Date | 05/08/2012 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Review Memo |
Review Memo
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Approval Order Statement
Approval for two new families of temporary external pacemaker pulse generators. New features include: 1) redel pacing wire connection adapters; 2) trigger modes vt and sst; 3) sensitivity settings up to 20 mv for the reocor s model; and 3) programmable av delay up to 400 ms. The device, as modified will be marketed under the trade names reocor s and reocor d and is indicated for: temporary pacing; temporary treatment of arrhythmias and heart block; symptomatic sinus bradycardia; pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; termination of supraventricular tachyarrhythmias; prophylactic pacing for prevention of arrhythmias; emergency pacing; and checking pacing thresholds. |
| Approval Order |
Approval Order
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