PMA P080012S025
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S025
- Product code
- LKK
- Decision date
- 2015-04-08
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- ADDITION OF AN ALTERNATE O-RING RAW MATERIAL SUPPLIER.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S025
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2015-04-08
- Decision code
- OK30
- Date received
- 2015-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE O-RING RAW MATERIAL SUPPLIER.