|
Device | BRAVA C RT-D; VIVA S CRT-D; VIVA XT CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S410 |
Date Received | 11/19/2013 |
Decision Date | 12/17/2013 |
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 MANUFACTURE UPDATE TO THE 0.8 ÌM BICMOS (BIPOLAR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) PROCESS FLOW AT THE IC SUPPLIER. |