Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | INTERSTIM THERAPY |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE, N.E. MINNEAPOLIS, MN 55432 |
PMA Number | P970004 |
Supplement Number | S047 |
Date Received | 12/21/2007 |
Decision Date | 01/17/2008 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF AN INSERT-MOLDED PROCESS TO MANUFACTURE THE BOND PAD ARRAY (BPA) IN PLACE OF A PRESS-FIT MANUFACTURING METHOD. |
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