The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 473-03 Pacing Lead.
Device ID | K844272 |
510k Number | K844272 |
Device Name: | MODEL 473-03 PACING LEAD |
Classification | Permanent Pacemaker Electrode |
Applicant | INTERMEDICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-05 |
Decision Date | 1985-03-28 |