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 | FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616 |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960006 |
Supplement Number | S005 |
Date Received | 07/11/2001 |
Decision Date | 02/04/2002 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATION TOOL MODEL 6616. THE FLEXTEND PACING LEADS MODELS 4086, 4087, AND 4088 ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR. |
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