|
Device | MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE |
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 | S021 |
Date Received | 09/06/2001 |
Decision Date | 12/21/2001 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODEL 2490A CARELINK MONITOR WITH MODEL 2491 DDMA SERVER-RESIDENT SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 2490A CARELINK MONITOR AND IS INDICATED FOR USE IN THE TRANSFER OF PATIENT DATA FROM MEDTRONIC GEM II ICDS (GEM II VR MODEL 7229 AND GEM II DR MODEL 7273). |