|
Device | INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S055 |
Date Received | 11/26/2008 |
Decision Date | 01/23/2009 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) REPLACEMENT OF THE POLYMIDE TUBING WITH POLYETHERETHERKTONE (PEEK) TUBING ON THE PULSE GENERATOR PG HEADER ASSEMBLIES; 2) THE USE OF A COMBINATION OF NATURAL AND COLORIZED PEEK TO ASSIST MANUFACTURING OPERATORS; AND 3) THE ADDITION OF AN EXTRA PLASMA CLEANING STEP TO ENSURE THAT THE BOND FORMED BETWEEN THE MEDICAL ADHESIVE APPLIED TO THE BASE OF THE WIRE AND THE PEEK INSULATION IS STRONG. |