PMA P890055S027
- Device
- CODMAN 3000 IMPLANTABLE DRUG DELIVERY SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S027
- Product code
- LKK
- Decision date
- 2010-12-22
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.
Current openFDA PMA Record#
- Device
- CODMAN 3000 IMPLANTABLE DRUG DELIVERY SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S027
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2010-12-22
- Decision code
- OK30
- Date received
- 2010-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.