PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
FDA premarket approval P080012/S016 · decided 2013-07-02
Approval details
- PMA number
- P080012
- Supplement
- S016
- 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
- 2013-04-05
- Decision date
- 2013-07-02
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE CANNULA STRAIN RELIEF AND FILTER SEAL, WHICH ARE BOTH COMPONENTS OF THE IMPLANTABLE PUMP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.