21 CFR 870.3730 — Tools, Pacemaker Service
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3730
Identification
Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTF | Tools, Pacemaker Service | 1 | 2 |
