|
Device | ASCENDA CATTHETER ORIENTATION |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S266 |
Date Received | 12/16/2016 |
Decision Date | 01/13/2017 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Reorient the spinal segment catheter and the spinal segment catheter revision kit within the Ascenda Catheter Assembly (Model 8780) and the Ascenda Catheter Revision Kit Assembly (Model 8782) sterile packages. |