Definition: To Be Implanted To Reinforce Soft Tissue Or Bone Where Weakness Exists. Intended To Be Used Wherever Temporary Wound Support Is Required, To Reinforce Soft Tissues Where Weakness Exists In The Urological, Gynecological, Or Gastrointestinal Anatomy, O
| Device Type ID | 5819 |
| Device Name | Surgical Film |
| Physical State | Absorbable Solid Form Of Poly(hydroxybutyrate) |
| Technical Method | Material Is Isolated From Prokaryotic Cells Produced By Recombinant Deoxyribonucleic Acid (DNA) Methods |
| Target Area | Soft Tissue And Bone |
| Regulation Description | Surgical Mesh. |
| 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 | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5819 |
| Device | Surgical Film |
| Product Code | OOD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TEPHA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Insufficient Information | 49 |
No Apparent Adverse Event | 6 |
Migration Or Expulsion Of Device | 4 |
Defective Device | 4 |
Microbial Contamination Of Device | 3 |
Device Contamination With Biological Material | 3 |
Torn Material | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Shelf Life Exceeded | 1 |
Hole In Material | 1 |
Material Protrusion / Extrusion | 1 |
Contamination During Use | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 79 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tepha Incorporated | II | Jan-05-2017 |