PROSTATRON
FDA premarket approval P950014/S008 · decided 1997-11-07
Approval details
- PMA number
- P950014
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSTATRON
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1997-08-28
- Decision date
- 1997-11-07
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a new sterilization facility located at Griffith Micro Science, 8 rue de Parmentier, 60290 Rantigny, France.
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