|
Device | COGNIS PULSE GENERATORS - MODELS N118 & N119 |
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 | S234 |
Date Received | 03/15/2010 |
Decision Date | 04/02/2010 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR 2ND SUPPLIER (IXYS) TO PROVIDE SCR/ANODE GATE THYRISTORS FOR THE SUPER OUTPUT MODULE (SOM) OF THE COGNIS/TELIGEN PGS. |