Definition: Call For PMAs 12/30/87 (52 FR 36883 10/1/87))
| Device Type ID | 3943 |
| Device Name | Clip, Tubal Occlusion |
| Regulation Description | Contraceptive Tubal Occlusion Device (TOD) And Introducer. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | PMA |
| CFR Regulation Number | 884.5380 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | HGB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3943 |
| Device | Clip, Tubal Occlusion |
| Product Code | HGB |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Contraceptive Tubal Occlusion Device (TOD) And Introducer. |
| CFR Regulation Number | 884.5380 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 2 |
Electrode | 2 |
| Total Device Problems | 4 |