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 | EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR |
Generic Name | SYSTEM, ESOPHAGEAL PACING |
Applicant | CARDIO COMMAND 4920 WEST CYPRESS ST. STE.110 TAMPA, FL 33607 |
PMA Number | P860008 |
Supplement Number | S018 |
Date Received | 06/04/2004 |
Decision Date | 08/27/2004 |
Product Code |
LPA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS. THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.) |
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