|
Device | THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S022 |
Date Received | 06/03/2003 |
Decision Date | 07/02/2003 |
Product Codes |
DTB DXY |
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 BIOCOMPATIBLE ADHESIVE TO THE LEAD WHICH WILL ENHANCE THE ABILITY TO MAINTAIN THE POSITION OF THE DRUG-ELUTING COLLAR AT ITS DESIGNED LOCATION. |