The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Peripheral Nerve Stimulation.
Device ID | K982902 |
510k Number | K982902 |
Device Name: | PERIPHERAL NERVE STIMULATION |
Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
Contact | David H Mueller |
Correspondent | David H Mueller MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
Product Code | GZF |
CFR Regulation Number | 882.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-14 |
Decision Date | 1998-11-10 |