|
Device | EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S074 |
Date Received | 09/02/2005 |
Decision Date | 02/16/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A CLARIFICATION AND INSPECTION STEP TO THE PROXIMAL ELECTRODE MANUFACTURING ASSEMBLY PROCESS FOR EASYTRAK LEADS. |