| 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 | INTERSTIM THERAPY FOR URINARY CONTROL |
|---|
| Classification Name | stimulator, electrical, implantable, for incontinence |
|---|
| Regulation Number | 876.5270 |
|---|
| Applicant | MEDTRONIC VASCULAR |
|---|
| PMA Number | P970004 |
|---|
| Supplement Number | S004 |
|---|
| Date Received | 10/21/1998 |
|---|
| Decision Date | 04/15/1999 |
|---|
| Product Code | |
| Docket Number | 99M-1306 |
|---|
| Notice Date | 07/12/1999 |
|---|
| Advisory Committee |
Gastroenterology/Urology |
|---|
| Supplement Type | panel track |
|---|
| Supplement Reason | labeling change - indications |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the medtronic(r) interstim(r) system for urinary control. This device is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments. |
| Approval Order |
Approval Order
|
|
|
