|
Device | FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S072 |
Date Received | 07/21/2015 |
Decision Date | 08/18/2015 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement REMOVE CIRCULAR TOOLS FROM USE IN THE MANUFACTURING OF FINELINE II PACING LEADS. |