Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S041 · decided 2017-05-31
Approval details
- PMA number
- P080012
- Supplement
- S041
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2017-05-01
- Decision date
- 2017-05-31
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for the addition of a dimensional measurement to the current inspection procedure for the Flow Activated Safety Valve (FAV) Access Port Body component to measure the counter-sink depth of the O-ring sealing surface, as specified in change ECO 16-80.
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