CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S057 · decided 2014-07-11
Approval details
- PMA number
- P890055
- Supplement
- S057
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2014-06-06
- Decision date
- 2014-07-11
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS BELGIUM (PETIT-RECHAIN) S.A. IN VERVIERS, BELGIUM.
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