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 II WELDING PROCESSES MONITORS AND CONTROLS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S267 |
Date Received | 01/27/2017 |
Decision Date | 02/21/2017 |
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 Addition of process monitors of the weld hardness, penetration, pull strength; as well as the addition of a process control that ensures the focus of the z-axis location at the laser welding process is locked on predefined tolerances; to the SynchroMed II weld processes. |
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