FDA UDI
In Commercial Distribution
🇺🇸 United States
SYNERGY MEGATRON™
DI: 08714729985587
·
Model: H7493942812400
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SYNERGY MEGATRON™
- Primary DI
- 08714729985587
- Version / Model
- H7493942812400
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-26
- Public Version
- 4
- Public Version Date
- 2023-05-11
- Public Version Status
- Update
- Public Device Record Key
- 614886b2-4360-44cf-9995-187dcc8535b9
Device Description
Everolimus-Eluting Platinum Chromium Coronary Stent System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIQ | Coronary drug-eluting stent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58771 | Drug-eluting coronary artery stent, bioabsorbable-polymer-coated | A non-bioabsorbable metal tubular mesh structure covered with a bioabsorbable polymer that contains a drug, designed to be implanted via a delivery catheter into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug is slowly released as the polymer degrades and is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Some types may be dedicated to implantation across a coronary artery bifurcation. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729985587 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150003 | 054 |
| P150003 | 088 |
| P150003 | 090 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Length | 12 | Millimeter | |
| Stent Diameter | 4 | Millimeter |