INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
FDA premarket approval P800036/S036 · decided 2006-06-23
Approval details
- PMA number
- P800036
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2006-04-21
- Decision date
- 2006-06-23
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Wellesley, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE AT CODMAN & SHURTLEFF, INC.RAYNHAM, MASSACHUSETTS.
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