|
Device | FINELINE II & THINLINE II |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S038 |
Date Received | 08/01/2006 |
Decision Date | 02/28/2007 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement PROCESS CHANGE TO THE FINELINE II AND THINLINE II J-FORMING MANUFACTURING METHOD TO IMPROVE RETENTION CHARACTERISTICS OF THE ATRIAL J-SHAPE. |