PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S013 · decided 2013-06-03
Approval details
- PMA number
- P080012
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2013-03-04
- Decision date
- 2013-06-03
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR ADDING AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE SUTURE WINGS (STRAIGHT AND 90 DEGREE) THAT ARE SUPPLIED IN THE CATHETER KIT.
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