The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Intermedics 430-07 Bipol Implant Endocard Pac Lead.
Device ID | K902672 |
510k Number | K902672 |
Device Name: | INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD |
Classification | Permanent Pacemaker Electrode |
Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
Contact | David A Teicher |
Correspondent | David A Teicher INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-18 |
Decision Date | 1991-03-01 |