| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
| |
| Trade Name | PROSTATRON |
|---|
| Classification Name | system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
|---|
| Generic Name | prostate (bph) microwave apparatus |
|---|
| Applicant | EDAP TECHNOMED, INC. |
|---|
| PMA Number | P950014 |
|---|
| Supplement Number | S014 |
|---|
| Date Received | 06/09/1998 |
|---|
| Decision Date | 06/09/1998 |
|---|
| Product Code | |
| Advisory Committee |
Gastroenterology/Urology |
|---|
| Supplement Type | real-time process |
|---|
| Supplement Reason | change design/components/specifications - software |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval for an upgrade to the prostatron's (tm) operating software to prostasoft 4. 0 (aslo referred to as "prostasoft 98"). |
|
|
