|
Device | FRONTIER/FRONTIER II FAMILY OF CRT-P |
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 | S046 |
Date Received | 08/04/2008 |
Decision Date | 01/15/2009 |
Product Code |
NKE |
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 A MANUFACTURING PROCESS CHANGE FOR HYBRID ASSEMBLY. |