Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S060 · decided 2019-09-23
Approval details
- PMA number
- P080012
- Supplement
- S060
- 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
- 2019-07-25
- Decision date
- 2019-09-23
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for introducing Software Version 2.01.5 for the Prometra Clinician Programmer, Cat. Nos. 12828 and 13828, used with Prometra and Prometra II Programmable Pumps and minor labeling changes to explain reduced functionality accompanying this revision.
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