|
Device | SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S339 |
Date Received | 02/22/2012 |
Decision Date | 04/16/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS. |