|
Device | FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS |
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 | S078 |
Date Received | 03/09/2011 |
Decision Date | 08/02/2011 |
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 ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT. |