Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S050 · decided 2019-01-31
Approval details
- PMA number
- P080012
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2018-02-06
- Decision date
- 2019-01-31
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for the addition of baclofen (baclofen injection, intrathecal, 500-2000 microgram/mL) to the Prometra Programmable Infusion Pump System indications for use and corresponding labeling changes to the device system.
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