INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
FDA premarket approval P800036/S038 · decided 2014-08-01
Approval details
- PMA number
- P800036
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2014-06-27
- Decision date
- 2014-08-01
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX (STERIS) IN NORTHBOROUGH, MASSACHUSETTS.
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