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, DRUG DELIVERY INFUSION PUMP SYNCHROMED FAMILY, DRUG DELIVERY KITS FOR REVISIONS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S197 |
Date Received | 09/23/2013 |
Decision Date | 10/22/2013 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS. |
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