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. |
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Device | DRUG DELIVERY CATHETERS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S209 |
Date Received | 06/25/2014 |
Decision Date | 07/24/2014 |
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 MANUFACTURING LINE MOVE ON THE SAME CHASKA, MINNESOTA CAMPUS, CHANGE IN THE INSPECTION ASSEMBLY PROCESS, REMOVAL OF A CLEANING STEP, AND WILL DISCONTINUING A MANUAL FINGERPULL TEST. |
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