|
Device | THINLINE II/FINELINE II STEROX PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S018 |
Date Received | 02/20/2001 |
Decision Date | 04/06/2001 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF MANNITOL AS AN ALTERNATE MATERIAL TO COVER THE HELIX ON THE ABOVE REFERENCED ACTIVE FIXATION PACING LEADS. THE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR. |