PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
FDA premarket approval P080012/S032 · decided 2015-11-24
Approval details
- PMA number
- P080012
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2015-10-26
- Decision date
- 2015-11-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- TO MODIFY THE MANUFACTURING PROCEDURE FOR THE PATIENT THERAPY CONTROLLER (PTC) TO REROUTE THE PTC'S POWER CABLE WITHIN THE ASSEMBLY TO PREVENT IT FROM DAMAGE. ADDITIONALLY, UPDATE THE FINAL RELEASE TEST TO ADD A "BOLUS TEST" TO FURTHER VERIFY THE OPERATION OF THE PTC PRIOR TO RELEASE.
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