PMA P860004S306
- Device
- SynchroMed Infusion Sysstem, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S306
- Product code
- LKK
- Decision date
- 2018-05-31
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Removal of bias voltage during cool-down and removal of transfer time requirement for hybrid burn-in test.
Current openFDA PMA Record#
- Device
- SynchroMed Infusion Sysstem, Ascenda Intrathecal Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S306
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2018-05-31
- Decision code
- OK30
- Date received
- 2018-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of bias voltage during cool-down and removal of transfer time requirement for hybrid burn-in test.