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. |
|
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 | S207 |
Date Received | 10/29/2015 |
Decision Date | 11/20/2015 |
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 DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN). |
|
|