DTBClass III

Permanent Pacemaker Electrode

21 CFR 870.3680 / Cardiovascular

DTB is the FDA product code for Permanent Pacemaker Electrode, a class III device type, regulated under 21 CFR 870.3680. As of 2026-09-10, FDA records hold 487 510(k) clearances under this code, the most recent dated 2006-07-10, and 8 recalls.

Classification record

Product code: DTB
Device name: Permanent Pacemaker Electrode
Regulation: 21 CFR 870.3680
Device class: Class III
Review panel: Cardiovascular
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 487
Ingested recalls: 8

Clearances, product code DTB

By decision year

487 clearances under product code DTB with a decision year between 1976 and 2006, 1985 the highest year at 56.

Show the numbers

510(k) clearances under FDA product code DTB by decision year
Year	Clearances
1976	3
1977	15
1978	21
1979	31
1980	23
1981	40
1982	18
1983	38
1984	8
1985	56
1986	45
1987	24
1988	31
1989	19
1990	17
1991	20
1992	8
1993	11
1994	7
1995	6
1996	13
1997	3
1998	6
1999	4
2000	5
2001	3
2002	5
2003	4
2004	2
2006	1

Applicants with the most clearances

Product code DTB

Applicants holding the most 510(k) clearances under product code DTB
Applicant	Clearances
Intermedics, Inc.	105
Medtronic, Inc.	69
Telectronics, Inc.	35
Pacesetter Systems	33
BIOTRONIK AG	26
Daig Corp.	23
Oscor Medical Corp.	22
Oscor Inc.	20
Biotronik Sales, Inc.	15
Cordis US Corp.	13

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order