PMA P890055S021
- Device
- GEM MODEL 7227 IMPLANTABLE DEVICE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S021
- Product code
- LKK
- Decision date
- 2007-09-07
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX, NORTHBOROUGH, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- GEM MODEL 7227 IMPLANTABLE DEVICE
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S021
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2007-09-07
- Decision code
- APPR
- Date received
- 2007-08-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX, NORTHBOROUGH, MASSACHUSETTS.