MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S029 · decided 2011-03-15
Approval details
- PMA number
- P890055
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2011-01-18
- Decision date
- 2011-03-15
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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