PMA P950014S009
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S009
- Product code
- MEQ
- Decision date
- 1997-09-24
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- Approval for the following changes in intended to minimize the risk of Prostaprobe balloon deflation difficulty: 1)modification of the Prostaprobe manufacturing procedures, and 2) addition of a labeling precaution.
Current openFDA PMA Record#
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S009
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1997-09-24
- Decision code
- APPR
- Date received
- 1997-09-18
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the following changes in intended to minimize the risk of Prostaprobe balloon deflation difficulty: 1)modification of the Prostaprobe manufacturing procedures, and 2) addition of a labeling precaution.