|
Device | FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S017 |
Date Received | 07/13/2006 |
Decision Date | 08/09/2006 |
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 CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS. |