|
Device | Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D |
Generic Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 coral sea street n.e. mounds view, MN 55112 |
PMA Number | P010031 |
Supplement Number | S729 |
Date Received | 01/08/2021 |
Decision Date | 02/03/2021 |
Product Code |
NIK |
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 Manufacturing location change and processing aid at a raw material supplier. |