|
Device | FRONTIER/FRONTIER II/ANTHEM/AESCULA |
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 | S064 |
Date Received | 11/25/2009 |
Decision Date | 05/11/2011 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO. |