|
Device | ANTHEM, FRONTIER II CRT-PS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S082 |
Date Received | 04/19/2011 |
Decision Date | 12/04/2012 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |