MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S031 · decided 2013-02-12
Approval details
- PMA number
- P890055
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2011-01-18
- Decision date
- 2013-02-12
- Days to decision
- 756 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MEDSTREAM REFILL KIT AND O.R. PREP KIT. THE PMA SUPPLEMENT ALSO REQUESTED APPROVAL FOR STERILIZATION TO OCCUR AT STERIS ISOMEDIX SERVICES IN NORTHBOROUGH, MASSACHUSETTS AND KIT PACKAGING TO OCCUR AT CONTECH MEDICAL, INC., IN PROVIDENCE, RHODE ISLAND.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.