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 | SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD |
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 | S001 |
Date Received | 10/02/1998 |
Decision Date | 04/09/1999 |
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 several new lead models: the SWEET PICOTIP(TM) Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads. These devices are indicated for chornic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator. |
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