Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S051 · decided 2018-08-17
Approval details
- PMA number
- P080012
- Supplement
- S051
- 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
- 2018-05-21
- Decision date
- 2018-08-17
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for changes made to the dimensions of the Access Port Spacer part in the PROMETRA Programmable Infusion Pump System.
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