PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
FDA premarket approval P080012/S035 · decided 2016-08-31
Approval details
- PMA number
- P080012
- Supplement
- S035
- 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
- 2016-08-05
- Decision date
- 2016-08-31
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Inspection fixtures, inspection set-up, and manufacturing fixture changes used for verifying and assembling the Prometra and Prometra II pumps.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.