Model 400 Implantable Infusion Pump
FDA premarket approval P800036/S039 · decided 2016-08-29
Approval details
- PMA number
- P800036
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Model 400 Implantable Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2016-08-02
- Decision date
- 2016-08-29
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.
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