IMPLANT AID SPLICING CRIMP & SLEEVE
Device Facts
| Record ID | K813518 |
|---|---|
| Device Name | IMPLANT AID SPLICING CRIMP & SLEEVE |
| Applicant | Intermedics, Inc. |
| Product Code | KFJ · Cardiovascular |
| Decision Date | Jan 12, 1982 |
| 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.
