JOQClass II
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
21 CFR 870.1750 / Cardiovascular
JOQ is the FDA product code for Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only), a class II device type, regulated under 21 CFR 870.1750. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- JOQ
- Device name
- Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- Regulation
- 21 CFR 870.1750
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 18
- Ingested recalls
- 3
Clearances, product code JOQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1985 | 3 |
| 1986 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2007 | 2 |
| 2009 | 1 |
| 2018 | 1 |
Applicants with the most clearances
Product code JOQ| Applicant | Clearances |
|---|---|
| Medtronic, Inc. | 4 |
| Abbott Medical | 3 |
| Micropace Pty. Ltd. | 2 |
| Cordis US Corp. | 1 |
| Ep Medical, Inc. | 1 |
| Ep Technologies, Inc. | 1 |
| Fischer Medical | 1 |
| Fischer Medical Technologies, Inc. | 1 |
| Heartware Intl. Corp. | 1 |
| Radionics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
