Definition: Call For Pmas To Be Filed By 7/9/91 Per 56 Fr 14627 On 4/10/91
| Device Type ID | 5530 |
| Device Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Regulation Description | Silicone Gel-filled Breast Prosthesis. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | PMA |
| CFR Regulation Number | 878.3540 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | FTR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5530 |
| Device | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Product Code | FTR |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Silicone Gel-filled Breast Prosthesis. |
| CFR Regulation Number | 878.3540 [🔎] |
| Device Problems | |
|---|---|
Material Rupture | 2543 |
Patient-Device Incompatibility | 642 |
Adverse Event Without Identified Device Or Use Problem | 420 |
No Apparent Adverse Event | 292 |
Migration Or Expulsion Of Device | 73 |
Fluid Leak | 67 |
Insufficient Information | 43 |
Gel Leak | 35 |
Appropriate Term/Code Not Available | 31 |
Migration | 21 |
Device Contamination With Chemical Or Other Material | 15 |
Break | 9 |
Device Markings / Labelling Problem | 8 |
Use Of Device Problem | 8 |
Malposition Of Device | 7 |
Device Contaminated During Manufacture Or Shipping | 6 |
Material Deformation | 6 |
Delivered As Unsterile Product | 6 |
Folded | 5 |
Manufacturing, Packaging Or Shipping Problem | 5 |
Device Expiration Issue | 5 |
Tear, Rip Or Hole In Device Packaging | 4 |
Improper Or Incorrect Procedure Or Method | 3 |
Material Discolored | 3 |
Device Issue | 3 |
Implant, Removal Of | 2 |
Contamination During Use | 2 |
Explanted | 2 |
Shipping Damage Or Problem | 1 |
Component Missing | 1 |
Degraded | 1 |
Contamination / Decontamination Problem | 1 |
Connection Problem | 1 |
Extrusion | 1 |
Elective Replacement | 1 |
Clumping In Device Or Device Ingredient | 1 |
Device Appears To Trigger Rejection | 1 |
Fracture | 1 |
Fungus In Device Environment | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Out-Of-Box Failure | 1 |
Incorrect Device Or Component Shipped | 1 |
Peeled / Delaminated | 1 |
Rupture Due To Capsulotomy | 1 |
| Total Device Problems | 4283 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Mentor Texas, LP. | II | Aug-03-2016 |