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 SYSTEM |
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 | S208 |
Date Received | 11/23/2015 |
Decision Date | 12/23/2015 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO. |
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