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FDA PMA Number P080012, PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA PMA Number P080012, PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
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Request: PMA applications/submission files and all subsequent correspondences and submissions of information for PMA number P080012, including supplements S057, S059, and S065
Request Year: 2023
PMA Number: P080012
Device: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Generic Name: Pump, infusion, implanted, programmable
Manufacturer: Infusyn Therapeutics, LLC
Product Code: LKK
Date Received: 04/11/2008
Decision Date: 02/07/2012
Notice Date: 02/27/2012
Request Year: 2023
PMA Number: P080012
Device: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Generic Name: Pump, infusion, implanted, programmable
Manufacturer: Infusyn Therapeutics, LLC
Product Code: LKK
Date Received: 04/11/2008
Decision Date: 02/07/2012
Notice Date: 02/27/2012
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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