| 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 | MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER |
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| Generic Name | Pulse-generator, pacemaker, external |
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| Applicant | PACE MEDICAL
391 TOTTEN POND RD.
WALTHAM, MA 02451 |
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| PMA Number | P920032 |
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| Supplement Number | S008 |
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| Date Received | 08/16/2001 |
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| Decision Date | 02/20/2002 |
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| Product Codes |
DTE JOQ |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE MICRO-PACE MODEL 4580. THE DEVICE IS INDICATED FOR "ANY CLINICAL SITUATION IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE. SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION. ADDITIONALLY, TEMPORARY CARDIAC PACING HAS BEEN USED TO OVERDRIVE AND THEREBY TERMINATE ATRIAL ARRHYTHMIAS, INCLUDING ATRIAL FLUTTER. IT HAS BEEN USED IN PREPARATION FOR PERMANENT PACEMAKER IMPLANTATION TO ASCERTAIN THE THRESHOLDS FOR SENSING AND PACING ON THE ACUTE LEAD SYSTEM." |
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