The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic External Pulse Generator (epg).
| Device ID | K132924 |
| 510k Number | K132924 |
| Device Name: | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Eric Kalmes |
| Correspondent | Eric Kalmes MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2013-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169508767 | K132924 | 000 |
| 00643169305120 | K132924 | 000 |
| 00643169230859 | K132924 | 000 |