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Device | ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM |
Generic Name | SYSTEM, ESOPHAGEAL PACING |
Applicant | CARDIO COMMAND 4920 WEST CYPRESS ST. STE.110 TAMPA, FL 33607 |
PMA Number | P860008 |
Supplement Number | S022 |
Date Received | 06/18/2012 |
Decision Date | 07/18/2012 |
Product Code |
LPA |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A NEW PIECE OF EQUIPMENT USED TO CUT AND STRIP PACING WIRES AND SHRINK TUBING. |