|
Device | MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S255 |
Date Received | 06/27/2016 |
Decision Date | 07/20/2016 |
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 Implementation of peel strength testing in the manufacturing lines at Medtronic Puerto Rico Operations Co. Villalba and Medtronic Puerto Rico Operations Juncos. |