|
Device | THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S019 |
Date Received | 10/04/2001 |
Decision Date | 10/26/2001 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CREATE SEPARATE ACCESSORY PACKS WHICH WILL INCLUDE THE MODELS 6220 AND 6221 SUTURE SLEEVES. |