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 | MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER |
Generic Name | Pulse-generator, pacemaker, external |
Applicant | PACE MEDICAL 391 TOTTEN POND RD. WALTHAM, MA 02451 |
PMA Number | P920032 |
Supplement Number | S006 |
Date Received | 01/18/2001 |
Decision Date | 04/06/2001 |
Product Codes |
DTE JOQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE TEMPORARY PACEMAKERS BY REPLACING THE ZENER DIODES USED FOR PROTECTING THE INTERNAL ELECTRONICS FROM HIGH VOLTAGE TRANSIENTS WITH A TRANSIENT VOLTAGE SUPPRESSOR. |
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