Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | CONCERTO II CRT-D, CONSULTA ICD, MAXIMO CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S384 |
Date Received | 06/26/2013 |
Decision Date | 07/26/2013 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE TO THE NEXT GENERATION HYBRID TESTER TO RELEASE 35.0. |
|
|