|
Device | ACUITY STEERABLE LEAD SYSTEM |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P050046 |
Supplement Number | S020 |
Date Received | 08/19/2013 |
Decision Date | 09/17/2013 |
Product Code |
OJX |
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 ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES. |