|
Device | THINLINE 2 FINELINE 2 |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S029 |
Date Received | 12/20/2005 |
Decision Date | 01/19/2006 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A SECOND SUPPLIER FOR THE ELECTRODE RING COMPONENT USED IN THE FINELINE II / THINLINE II FAMILY OF LEADS. |