| 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 | TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS |
|---|
| Classification Name | lithotriptor, extracorporeal shock-wave,urological |
|---|
| Generic Name | lithotripter |
|---|
| Regulation Number | 876.5990 |
|---|
| Applicant | MEDIREX, INC. |
|---|
| PMA Number | P920034 |
|---|
| Supplement Number | S002 |
|---|
| Date Received | 01/21/1998 |
|---|
| Decision Date | 03/05/1998 |
|---|
| Product Code | |
| Advisory Committee |
Gastroenterology/Urology |
|---|
| Supplement Type | normal 180 day track |
|---|
| Supplement Reason | labeling change - instructions |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval for non-electrocardiographic (ecg) gating in patients with renal and upper tract calculi. |
|
|
