PMA P950014S005
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S005
- Product code
- MEQ
- Decision date
- 1996-11-22
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- ADDITION OF A PRECAUTIONARY STATEMENT TO THE LABELING REGARDING THE STEPS THAT SHOULD BE TEKN IN THE EVENT OF PROSTAPROBE BALLOON DEFLATION DIFFICULTY
Current openFDA PMA Record#
- Device
- PROSTATRON
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S005
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1996-11-22
- Decision code
- APPR
- Date received
- 1996-10-31
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- ADDITION OF A PRECAUTIONARY STATEMENT TO THE LABELING REGARDING THE STEPS THAT SHOULD BE TEKN IN THE EVENT OF PROSTAPROBE BALLOON DEFLATION DIFFICULTY