MEDTRONIC MODEL 5867-1A
Device Facts
| Record ID | K852236 |
|---|---|
| Device Name | MEDTRONIC MODEL 5867-1A |
| Applicant | Medtronic Vascular |
| Product Code | KFJ · Cardiovascular |
| Decision Date | Jul 11, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3710 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.