The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 5071 Myocardial Pacing Lead.
Device ID | K031274 |
510k Number | K031274 |
Device Name: | MODEL 5071 MYOCARDIAL PACING LEAD |
Classification | Permanent Pacemaker Electrode |
Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
Contact | Tina Benoit |
Correspondent | Tina Benoit MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-22 |
Decision Date | 2003-05-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00681490124454 | K031274 | 000 |
00681490124379 | K031274 | 000 |
00681490124300 | K031274 | 000 |
00681490124225 | K031274 | 000 |