|
Device | THINLINE II/ FINELINE II PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S012 |
Date Received | 05/15/2000 |
Decision Date | 06/07/2000 |
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 FIVE MINOR CHANGES MADE TO THE THINLINE II(TM) AND FINELINE II(TM) MANUFACTURING PROCESSES. |