|
Device | MICRONY FAMILY OF PACEMAKERS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P970013 |
Supplement Number | S041 |
Date Received | 06/28/2011 |
Decision Date | 08/17/2011 |
Product Codes |
LWP LWS NIK NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES. |