PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
FDA premarket approval P080012/S029 · decided 2015-09-01
Approval details
- PMA number
- P080012
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2015-06-04
- Decision date
- 2015-09-01
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR VERSION 1.02.1 OF THE PROMETRA TOUCHSCREEN PROGRAMMER SOFTWARE.
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