Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump
FDA premarket approval P080012/S047 · decided 2017-12-19
Approval details
- PMA number
- P080012
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2017-09-19
- Decision date
- 2017-12-19
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for modifications of product labeling as a result of MRI testing conducted on the Flowonix Prometra Programmable Infusion Pump System.
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