Efh-6F-W 433307
Efh-6F-W 433307 is a medical device (FDA Class III; FDA product code DTB, permanent pacemaker Electrode) made by BIOTRONIK SE & Co. KG, approved under FDA PMA P950037 on 11 Oct 1996 and listed in FDA GUDID since 17 Nov 2017 (UDI-DI 04035479157838), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04035479157838 | Date17 Nov 2017 | StatusListed |
| United States | FDA PMAAPPR | NumberP950037 | Date11 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 04035479157838
- FDA PMA database P950037
Across registries
- FDA PMA P950037 decided 11 Oct 1996 Active
- FDA GUDID UDI-DI 04035479157838 listed 17 Nov 2017 Listed
Timeline
- Approved FDA PMA P950037
- Listed FDA GUDID 04035479157838
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Efh-6F-W
- Generic name
- Implantable electrical stimulation lead suture sleeve
- Model / Ref / Catalog
- 433307
- Primary DI / UDI-DI
- 04035479157838
- FDA product code
- DTB
- GMDN term
- Implantable electrical stimulation lead suture sleeve
- Device class
- Class III
- Regulation number
- 870.3680
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DTB (permanent pacemaker Electrode).
- Unipolar-E Endocardial Tined Lead by Cook Pacemaker Corp.
- SUTURELESS MYOCARDIAL PACING LEAD by MEDTRONIC VASCULAR, INC.
- DNR Unipolar Permanent Pacemaker Electrode by Biotronik Sales, Inc.
- Endocardial Pacing Lead, Model 476-01 by Intermedics, Inc.
- Porous Tip Endocardial Lead by Daig Corp.
- Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads by Ela Medical, Inc.
- Model 486-01 Pacemaker Lead by Intermedics, Inc.
- Slim Vent Unipo Pacing Lead Using PolyU 90A, 30-281 by Telectronics, Inc.
- Wedge Tip, Small, Model #030-194 by Med Telectronics, Ltd.
- Medtronic Model 4951P Permanent Pacemaker Electrode by MEDTRONIC VASCULAR, INC.