The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing.
| Device ID | K140972 |
| 510k Number | K140972 |
| Device Name: | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | MEDTRONIC, INC. 1851 EAST DEERE AVE. Santa Ana, CA 92705 |
| Contact | Debra Taitague |
| Correspondent | Debra Taitague MEDTRONIC, INC. 1851 EAST DEERE AVE. Santa Ana, CA 92705 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-16 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169310111 | K140972 | 000 |
| 20643169310104 | K140972 | 000 |
| 20643169310098 | K140972 | 000 |
| 20643169310081 | K140972 | 000 |
| 20643169310074 | K140972 | 000 |