INFUSAID Implantable Infusion Pump and Accessories
FDA premarket approval P800036/S041 · decided 2020-02-07
Approval details
- PMA number
- P800036
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFUSAID Implantable Infusion Pump and Accessories
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2020-01-09
- Decision date
- 2020-02-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- Approval for a manufacturing site located at Intera Oncology, Inc., 65 William Street, Suite 200, Wellesley, Massachusetts, to conduct quality system activities.
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