PROSTATRON
FDA premarket approval P950014/S007 · decided 1997-10-27
Approval details
- PMA number
- P950014
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROSTATRON
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1997-08-06
- Decision date
- 1997-10-27
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a single-module version of the Prostatron, as well as minor hardware and software changes to both the single and dual-module Prostatron versions.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.