|
Device | D286 CURRENT DRAIN LIMITS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S348 |
Date Received | 02/04/2013 |
Decision Date | 02/28/2013 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE CURRENT DRAIN RELATED LIMITS FOR AN IC TO PREVENT EXCESSIVE YIELD FALLOUT. |