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 DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER |
Generic Name | Generator, pulse, pacemaker, external programmable (for electrophysiological studies only) |
Applicant | PACE MEDICAL 391 TOTTEN POND RD. WALTHAM, MA 02451 |
PMA Number | P920032 |
Supplement Number | S005 |
Date Received | 06/25/1999 |
Decision Date | 02/02/2000 |
Product Codes |
DTE JOQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval is for an alternate vendor located at Princeton Technology, Inc., 12 Park Avenue, Hudson, New Hampshire. |
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