The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Rapid Progeammer 3.0.
Device ID | K052374 |
510k Number | K052374 |
Device Name: | RAPID PROGEAMMER 3.0 |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
Contact | Katryna Warren |
Correspondent | Katryna Warren ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. 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 | 2005-08-30 |
Decision Date | 2005-11-22 |