|
Device | FINELINE II PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S023 |
Date Received | 12/03/2003 |
Decision Date | 12/19/2003 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A SPECIFICATION FOR THE CONDUCTOR-TO-TERMINAL PIN WELD STRENGTH. |