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 | PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S275 |
Date Received | 09/26/2014 |
Decision Date | 10/21/2014 |
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 ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY. |
|
|