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 | STAT PACE II |
Generic Name | SYSTEM, ESOPHAGEAL PACING |
Applicant | CARDIOCOMMAND, INC. 4920 WEST CYPRESS STREET SUITE 110 TAMPA, FL 33607-3837 |
PMA Number | P840002 |
Supplement Number | S011 |
Date Received | 03/09/2004 |
Decision Date | 10/01/2004 |
Product Code |
LPA |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING SITES LOCATED AT MARTECH MEDICAL PRODUCTS, BAJA CALIFORNIA, MEXICO AND HARLEYSVILLE, PENNSYLVANIA. |
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