|
Device | SYNCHROMED IMPLANTABLE INFUSION SYSTEM: PERCUTANEOUS INTRASPINAL CATHETER KIT |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S078 |
Date Received | 11/23/2005 |
Decision Date | 03/10/2006 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR INCLUSION OF THE B. BRAUN MEDICAL PERIFIX CATHETER CONNECTOR IN THE MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT. |