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Device | MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S100 |
Date Received | 05/17/2004 |
Decision Date | 07/21/2004 |
Product Codes |
DTB DXY KRG |
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 THE MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS. |