|
Device | Unify/ Unify Quadra/ Unify Assura / Quadra Assura MP |
Generic Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Applicant |
St. Jude Medical |
15900 valley view ct. |
sylmar, CA 91342-3577 |
|
PMA Number | P030054 |
Supplement Number | S341 |
Date Received | 11/13/2017 |
Decision Date | 12/07/2017 |
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
Elimination of certain non-destructive pull testing of wires on hybrid circuits. |