|
Device | Tendril MRI |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S001 |
Date Received | 02/08/2017 |
Decision Date | 02/21/2017 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Addition of an alternate analytical testing laboratory for monolithic controlled release devices and the addition of an alternate vendor to supply Polyhexamethylene Oxide which is used in the manufacture of Optim. |