|
Device | MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S202 |
Date Received | 01/28/2014 |
Decision Date | 02/25/2014 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR DEVICE REFILL KIT MODEL 8551TO REORDER THE WARNINGS AND PRECAUTIONS ACCORDING TO MEDICAL IMPORTANCE, TO REMOVE INFORMATION FOUND IN THE PREVIOUSLY APPROVED INSTRUCTIONS FOR USE THAT IS NOT APPLICABLE TO MODEL 8551, AND TO ALIGN VERBIAGE WITH THE UPDATED MODEL 856X REFILL KIT INSTRUCTIONS FOR USE. |