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 | MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01 |
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 | S054 |
Date Received | 04/02/2008 |
Decision Date | 05/30/2008 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE PROGRAMMING GUIDE FOR MODELS 8840 NVISION CLINICIAN PROGRAMMER AND 8870 NVISION APPLICATION CARD, TO BETTER DESCRIBE HOW TO DETERMINE THE BATTERY STATUS OF THE MODEL 3058 INTERSTIM IMPLANTABLE NEUROSTIMULATOR AND FOR ADDITIONAL MINOR LABELING CHANGES. |
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