Definition: To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts
| Device Type ID | 2085 |
| Device Name | Pancreatic Stent, Covered, Metallic, Removable |
| Physical State | Stent And Delivery System, Endoscope |
| Technical Method | Facilitates And Secures The Apposition Of Tissue For Transmural Placement Of Stent |
| Target Area | Pancreatic Pseudocysts Adherent To Bowel Wall |
| Regulation Description | Pancreatic Drainage Stent And Delivery System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5015 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2085 |
| Device | Pancreatic Stent, Covered, Metallic, Removable |
| Product Code | PCU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Pancreatic Drainage Stent And Delivery System. |
| CFR Regulation Number | 876.5015 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 117 |
Stent | 98 |
Premature Activation | 41 |
Migration Or Expulsion Of Device | 35 |
Difficult To Remove | 27 |
Positioning Problem | 19 |
Detachment Of Device Or Device Component | 17 |
Activation Failure Including Expansion Failures | 17 |
Catheter | 16 |
Tip | 16 |
Partial Blockage | 14 |
Flange | 13 |
Break | 10 |
Positioning Failure | 9 |
Appropriate Term/Code Not Available | 9 |
Migration | 9 |
Use Of Device Problem | 6 |
Human-Device Interface Problem | 5 |
Activation, Positioning Or Separation Problem | 4 |
Detachment Of Device Component | 4 |
Locking Mechanism | 3 |
Obstruction Of Flow | 3 |
Difficult Or Delayed Positioning | 3 |
Occlusion Within Device | 2 |
Fracture | 2 |
Material Integrity Problem | 2 |
Handpiece | 2 |
Device-Device Incompatibility | 2 |
Cover | 2 |
Material Deformation | 2 |
Entrapment Of Device | 2 |
Malposition Of Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Mechanical Problem | 1 |
Inadequate User Interface | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Unsealed Device Packaging | 1 |
Mechanical Jam | 1 |
Failure To Advance | 1 |
Retraction Problem | 1 |
| Total Device Problems | 520 |