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Device | MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) |
Generic Name | Pacemaker/icd/crt non-implanted components |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S139 |
Date Received | 09/30/2013 |
Decision Date | 04/11/2014 |
Product Code |
OSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE. |
Approval Order | Approval Order |