PMA P800036S038
- Device
- INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P800036
- Supplement
- S038
- Product code
- LKK
- Decision date
- 2014-08-01
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX (STERIS) IN NORTHBOROUGH, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
- Applicant
- Intera Oncology
- PMA number
- P800036
- Supplement
- S038
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2014-08-01
- Decision code
- APPR
- Date received
- 2014-06-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX (STERIS) IN NORTHBOROUGH, MASSACHUSETTS.