|
Device | ACUITY SPIRAL LEADS |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S383 |
Date Received | 12/22/2014 |
Decision Date | 03/19/2015 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGING FROM OXYFUME TO 100% ETHYLENE OXIDE STERILIZATION AND UPDATED LABELING. |