- Device
- DRUG dELIVERY ACCESSORIES, DRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY, DRUG DELIVERY KITS F
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S263
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2016-12-13
- Decision code
- OK30
- Date received
- 2016-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update of the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.3.