PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200
FDA premarket approval P080012/S007 · decided 2012-09-11
Approval details
- PMA number
- P080012
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2012-08-17
- Decision date
- 2012-09-11
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- USE OF AN ALTERNATE SUB-TIER SUPPLIER FOR A COMPONENT OF THE DEVICE.
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