| Device Type ID | 5527 |
| Device Name | Mesh, Surgical, Polymeric |
| 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 One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FTL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5527 |
| Device | Mesh, Surgical, Polymeric |
| Product Code | FTL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATRIUM MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ATRIUM MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
C.R. BARD INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 15 | |
COUSIN BIOTECH S.A.S. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
ETHICON INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PROXY BIOMEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROXY BIOMEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTHASOME | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTHASOME, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W.L. GORE & ASSOCIATES,INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 7314 |
Defective Device | 6974 |
Adverse Event Without Identified Device Or Use Problem | 6768 |
Appropriate Term/Code Not Available | 2749 |
Migration Or Expulsion Of Device | 1006 |
Material Deformation | 219 |
Detachment Of Device Or Device Component | 174 |
Material Erosion | 162 |
Break | 114 |
Torn Material | 95 |
Material Separation | 86 |
Material Integrity Problem | 68 |
Material Split, Cut Or Torn | 62 |
No Apparent Adverse Event | 57 |
Loss Of Or Failure To Bond | 53 |
Hole In Material | 51 |
Failure To Adhere Or Bond | 49 |
Extrusion | 48 |
Migration | 45 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 45 |
Use Of Device Problem | 43 |
Folded | 42 |
Tear, Rip Or Hole In Device Packaging | 40 |
Patient Device Interaction Problem | 34 |
Material Perforation | 31 |
Detachment Of Device Component | 27 |
Material Protrusion / Extrusion | 25 |
Degraded | 25 |
Device Markings / Labelling Problem | 21 |
Unsealed Device Packaging | 19 |
Material Frayed | 17 |
Material Disintegration | 16 |
Product Quality Problem | 13 |
Deformation Due To Compressive Stress | 13 |
Material Too Rigid Or Stiff | 13 |
Material Rupture | 13 |
Device Expiration Issue | 13 |
Shelf Life Exceeded | 13 |
Contamination During Use | 12 |
Expiration Date Error | 11 |
Device Operates Differently Than Expected | 11 |
Delamination | 11 |
Packaging Problem | 9 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 8 |
Device Issue | 8 |
Device Contamination With Chemical Or Other Material | 7 |
Sticking | 6 |
Human-Device Interface Problem | 6 |
Patient-Device Incompatibility | 6 |
Device Dislodged Or Dislocated | 5 |
Explanted | 5 |
Device Damaged By Another Device | 5 |
Off-Label Use | 4 |
Device Slipped | 4 |
Microbial Contamination Of Device | 4 |
Split | 3 |
Kinked | 3 |
Mechanics Altered | 3 |
Material Fragmentation | 3 |
Peeled / Delaminated | 3 |
Bent | 3 |
Inflation Problem | 2 |
Unexpected Therapeutic Results | 2 |
Device Difficult To Setup Or Prepare | 2 |
Material Puncture / Hole | 2 |
Obstruction Of Flow | 2 |
Structural Problem | 2 |
Misassembled | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Incomplete Or Missing Packaging | 2 |
Device Packaging Compromised | 2 |
Entrapment Of Device | 2 |
Impedance Problem | 2 |
Difficult To Position | 2 |
Crack | 2 |
Overheating Of Device | 1 |
Implant Extrusion | 1 |
Cut In Material | 1 |
Incorrect Or Inadequate Test Results | 1 |
Inadequate User Interface | 1 |
Device Or Device Fragments Location Unknown | 1 |
Missing Value Reason | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Material Distortion | 1 |
Reaction | 1 |
Flaked | 1 |
Malfunction | 1 |
Malposition Of Device | 1 |
Biocompatibility | 1 |
Out-Of-Box Failure | 1 |
Ring | 1 |
Incorrect Device Or Component Shipped | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Physical Resistance / Sticking | 1 |
Inadequate Service | 1 |
Unraveled Material | 1 |
Difficult Or Delayed Positioning | 1 |
Component Missing | 1 |
Shipping Damage Or Problem | 1 |
Failure To Auto Stop | 1 |
| Total Device Problems | 26750 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atrium Medical Corporation | II | Feb-23-2018 |
| 2 | Covidien LLC | II | Nov-14-2018 |
| 3 | Covidien LLC | II | Jul-12-2018 |
| 4 | Davol, Inc., Subs. C. R. Bard, Inc. | II | Nov-07-2014 |
| 5 | Davol, Inc., Subs. C. R. Bard, Inc. | II | Jan-23-2014 |
| 6 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 7 | MAST Biosurgery USA, Inc | II | Feb-10-2015 |
| 8 | Novus Scientific Ab | II | Aug-19-2016 |
| 9 | Sofradim Production | II | Apr-26-2018 |
| 10 | Stryker Craniomaxillofacial Division | II | Feb-11-2015 |
| 11 | TYRX Inc. | II | Aug-15-2016 |