Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S045 · decided 2017-08-21
Approval details
- PMA number
- P080012
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2017-06-08
- Decision date
- 2017-08-21
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for revised protocol for the post-approval study (PAS) protocol.
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