PROSTATRON
FDA premarket approval P950014/S001 · decided 1996-06-20
Approval details
- PMA number
- P950014
- Supplement
- S001
- 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
- 1996-05-16
- Decision date
- 1996-06-20
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO SUPPLY THE PROSTATRON TREATMENT CATHETER (I.E., THE PROSTAPROBE) IN STERILE FORM
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