Definition: Call For PMAs To Be Filed By 11/17/99 Per 64 FR 45161 On 8/19/99
| Device Type ID | 5546 |
| Device Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Regulation Description | Silicone Inflatable 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 Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | PMA |
| CFR Regulation Number | 878.3530 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | FWM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5546 |
| Device | Prosthesis, Breast, Inflatable, Internal, Saline |
| Product Code | FWM |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Silicone Inflatable Breast Prosthesis. |
| CFR Regulation Number | 878.3530 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 10632 |
Material Rupture | 6014 |
Patient-Device Incompatibility | 1750 |
Adverse Event Without Identified Device Or Use Problem | 1367 |
No Apparent Adverse Event | 329 |
Migration Or Expulsion Of Device | 152 |
Appropriate Term/Code Not Available | 114 |
Migration | 65 |
Malposition Of Device | 60 |
Use Of Device Problem | 49 |
Device Contamination With Chemical Or Other Material | 43 |
Break | 39 |
Improper Or Incorrect Procedure Or Method | 34 |
Insufficient Information | 33 |
Folded | 20 |
Connection Problem | 14 |
Device Dislodged Or Dislocated | 12 |
Component Missing | 10 |
Material Deformation | 8 |
Off-Label Use | 7 |
Biofilm Coating In Device | 7 |
Device Appears To Trigger Rejection | 6 |
Leak / Splash | 5 |
Device Expiration Issue | 5 |
Device Markings / Labelling Problem | 4 |
Material Discolored | 4 |
Extrusion | 4 |
Deflation Problem | 3 |
Defective Component | 3 |
Implant, Removal Of | 3 |
Microbial Contamination Of Device | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Loss Of Or Failure To Bond | 2 |
Material Puncture / Hole | 1 |
Material Integrity Problem | 1 |
Contamination During Use | 1 |
Failure To Osseointegrate | 1 |
Implant Breakage Or Physical Damage | 1 |
Infusion Or Flow Problem | 1 |
Inflation Problem | 1 |
Gel Leak | 1 |
Material Perforation | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Problem | 1 |
Device Damaged Prior To Use | 1 |
Fungus In Device Environment | 1 |
Partial Blockage | 1 |
Out-Of-Box Failure | 1 |
Device Packaging Compromised | 1 |
| Total Device Problems | 20818 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Mentor Texas, LP. | II | May-11-2017 |