|
Device | FINELINE II/THINLINE II STEROX LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S039 |
Date Received | 03/19/2007 |
Decision Date | 04/18/2007 |
Product Code |
NVY |
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 FOR ELECTRODE TIP COMPONENT MODIFICATIONS AND MEDICAL ADHESIVE REPLACEMENT. |