The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 7499 Extension.
Device ID | K000445 |
510k Number | K000445 |
Device Name: | MEDTRONIC MODEL 7499 EXTENSION |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
Contact | Kathy Jo Fahey |
Correspondent | Kathy Jo Fahey MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-10 |
Decision Date | 2000-04-28 |