The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Rapid Programmer.
Device ID | K113611 |
510k Number | K113611 |
Device Name: | RAPID PROGRAMMER |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
Contact | Teri Gilio |
Correspondent | Teri Gilio ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-06 |
Decision Date | 2012-04-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAPID PROGRAMMER 76529829 2911547 Live/Registered |
Advanced Neuromodulation Systems, Inc. 2003-07-16 |