FDA PMA Number P030006, PROLIEVE THERMODILATATION SYSTEM
FDA PMA Number P030006, PROLIEVE THERMODILATATION SYSTEM
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Request: Volumes 23 and 24 of the HeartMate IP (Implantable Pneumatic) LVAS for BTT submission. PMA number P920014. These two volumes contain photos of 160 explanted HeartMate IPs.
Request Year: 2021
PMA Number: P030006
Device: PROLIEVE THERMODILATATION SYSTEM
Generic Name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Manufacturer: MEDIFOCUS, INC
Product Code: MEQ
Date Received: 03/24/2003
Decision Date: 02/19/2004
Notice Date: 03/09/2004
Request Year: 2021
PMA Number: P030006
Device: PROLIEVE THERMODILATATION SYSTEM
Generic Name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Manufacturer: MEDIFOCUS, INC
Product Code: MEQ
Date Received: 03/24/2003
Decision Date: 02/19/2004
Notice Date: 03/09/2004
- 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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