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 | SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S348 |
Date Received | 11/25/2019 |
Decision Date | 12/19/2019 |
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 Perform retest activities of the SynchroMed® Infusion System and Ascenda® Intrathecal Catheters port helium leak test (catheter leak test) manufacturing step and to separate the tube inflate inspection from the catheter leak test step. |
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