|
Device | THINLINE ENDOCARDIAL PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S010 |
Date Received | 09/14/1999 |
Decision Date | 03/29/2000 |
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 use of Nusil MED 4870 as an alternate material for the suture sleeve and extension of the shelf life of your devices to 4 years. |