PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
FDA premarket approval P030006/S005 · decided 2005-06-30
Approval details
- PMA number
- P030006
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Medifocus, Inc.
- Date received
- 2005-03-23
- Decision date
- 2005-06-30
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- APPROVAL FOR ACCELLENT JUAREZ (MANUFACTURING SITE) LOCATED IN, CHIHUAHUA, MEXICO; ACCELLENT EL PASO (WAREHOUSE) LOCATED IN EL PASO, TEXAS; AND STERIGENICS INTERNATIONAL, INC. (STERILIZER) LOCATED IN SANTA TERESA, NEW MEXICO.
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