PROSTATRON
FDA premarket approval P950014/S005 · decided 1996-11-22
Approval details
- PMA number
- P950014
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSTATRON
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1996-10-31
- Decision date
- 1996-11-22
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- ADDITION OF A PRECAUTIONARY STATEMENT TO THE LABELING REGARDING THE STEPS THAT SHOULD BE TEKN IN THE EVENT OF PROSTAPROBE BALLOON DEFLATION DIFFICULTY
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