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Device | STAT-PACE II ESOPHAGEAL PACING SYSTEM |
Generic Name | SYSTEM, ESOPHAGEAL PACING |
Applicant | CARDIOCOMMAND, INC. 4920 WEST CYPRESS STREET SUITE 110 TAMPA, FL 33607-3837 |
PMA Number | P840002 |
Supplement Number | S009 |
Date Received | 01/21/1997 |
Decision Date | 09/03/1997 |
Product Code |
LPA |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for design and labeling modification to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems. |