|
Device | CONTAK CD/EASYTRAK |
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 | S109 |
Date Received | 03/02/2006 |
Decision Date | 06/28/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF IN-LINE LAL TESTING (PYROGENICITY TESTING) TO THE INSPECTION PROCEDURE FOR EACH INCOMING LOT RECEIVED AT GUIDANT FOR THE UNIVERSAL FINISHING WIRE ACCESSORIES. |