PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S030 · decided 2016-01-12
Approval details
- PMA number
- P080012
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2015-10-13
- Decision date
- 2016-01-12
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR UPDATING THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM SOFTWARE TO VERSION 1.03.2. THE SOFTWARE UPDATE CONSOLIDATES THE CONFIGURATION DEVICE SOFTWARE WITH THE CLINICIAN PROGRAMMER.
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