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 | 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 | S269 |
Date Received | 02/06/2017 |
Decision Date | 03/08/2017 |
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 Allow the current pouch manufacturer (Oliver Tolas Healthcare Packaging) to pre-cut a Tyvek pouch that is per the specifications for the affected products, Spinal needle model number 8786 and 8787. |
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