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 | TAPSYSTEM 2A |
Generic Name | SYSTEM, ESOPHAGEAL PACING |
Applicant | CARDIOCOMMAND, INC. 4920 WEST CYPRESS STREET SUITE 110 TAMPA, FL 33607-3837 |
PMA Number | P840002 |
Supplement Number | S007 |
Date Received | 10/02/1995 |
Decision Date | 10/03/1997 |
Product Code |
LPA |
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 for a manufacturing site lcoated at Haller Industries, Inc. 4895 West Waters, Suite J, Tampa Florida. |
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