PMA P890055S076
- Device
- Codman OR Prep Kits
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S076
- Product code
- LKK
- Decision date
- 2020-12-16
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Replacing one inch refill needles with previously approved 1.5 inch refill needles in OR prep kit and corresponding labeling edits.
Current openFDA PMA Record#
- Device
- Codman OR Prep Kits
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S076
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacing one inch refill needles with previously approved 1.5 inch refill needles in OR prep kit and corresponding labeling edits.