PMA P950014S016
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S016
- Product code
- MEQ
- Decision date
- 1998-10-14
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- Approval for modifications to the Prostatron's(R) labeling which summarize the results of the postapproval study.
Current openFDA PMA Record#
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S016
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1998-10-14
- Decision code
- APPR
- Date received
- 1998-06-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the Prostatron's(R) labeling which summarize the results of the postapproval study.