PMA P990034S026
- Device
- ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT
- Applicant
- Medtronic, Inc.
- PMA number
- P990034
- Supplement
- S026
- Product code
- LKK
- Decision date
- 2011-12-07
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.
Current openFDA PMA Record#
- Device
- ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT
- Applicant
- Medtronic, Inc.
- PMA number
- P990034
- Supplement
- S026
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2011-12-07
- Decision code
- OK30
- Date received
- 2011-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.