|
Device | CONTAK RENEWAL TR MODELS H120 AND H125 |
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 | S015 |
Date Received | 08/15/2005 |
Decision Date | 09/08/2005 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES MADE TO THE SOFTWARE OF THE AUTOMATED SETSCREW PRELOAD SYSTEM FOR THE MODELS LISTED THAT WERE INADVERTENTLY LEFT OU OF A PREVIOUS 30-DAY NOTICE. |