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 | MODEL 855 REFILL KIT |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S163 |
Date Received | 11/07/2011 |
Decision Date | 04/27/2012 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT SURGICAL TECHNOLOGIES, INC. IN SAINT PAUL, MINNESOTA. |
|
|