|
Device | EPIC HF CRT-D SYSTEM |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S100 |
Date Received | 08/11/2008 |
Decision Date | 08/19/2008 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABLEING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER). |