|
Device | THINLINE II/ FINELINE II |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S014 |
Date Received | 05/26/2000 |
Decision Date | 11/21/2000 |
Product Codes |
DTB DXY |
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 SILICONE AND POLYURETHANE THINLINE(TM) II STEROX AND FINELINE(TM) II STEROID ELUTING PACING LEADS. THE DEVICES ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULSE GENERATOR. |