PMA P860004S075
- Device
- SYNCHROMED IMPLANTABLE INFUSION SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S075
- Product code
- LKK
- Decision date
- 2005-12-23
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR A MODIFIED CLEANING PROCESS OF THE PLATINUM/IRIDIUM CATHETER TIP OF THE MODEL 8731 CATHETER.
Current openFDA PMA Record#
- Device
- SYNCHROMED IMPLANTABLE INFUSION SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S075
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2005-12-23
- Decision code
- APPR
- Date received
- 2005-09-16
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFIED CLEANING PROCESS OF THE PLATINUM/IRIDIUM CATHETER TIP OF THE MODEL 8731 CATHETER.