MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S053 · decided 2014-01-22
Approval details
- PMA number
- P890055
- Supplement
- S053
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2013-12-23
- Decision date
- 2014-01-22
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR ADDITION OF A 100% INSPECTION TO VERIFY THE USE BY DATE ON THE LABELS OF THE MEDSTREAM IMPLANTABLE INFUSION PUMP SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.