FDA UDI
In Commercial Distribution
🇺🇸 United States
PROMUS Element™ Plus
DI: 08714729823766
·
Model: H7493911438350
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROMUS Element™ Plus
- Primary DI
- 08714729823766
- Version / Model
- H7493911438350
- Catalog Number
- H7493911438350
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 39323468-1124-4570-b04c-8d0b2a3b0cf6
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 |
|---|---|---|---|---|
| 56284 | Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated | A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is 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 coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included. | Yes | Active |
| 47732 | Coronary angioplasty balloon catheter, basic | A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729823766 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110010 | 001 |
| P110010 | 004 |
| P110010 | 006 |
| P110010 | 020 |
| P110010 | 021 |
| P110010 | 026 |
| P110010 | 028 |
| P110010 | 035 |
| P110010 | 051 |
| P110010 | 058 |
| P110010 | 083 |
| P110010 | 089 |
| P110010 | 090 |
| P110010 | 096 |
| P110010 | 099 |
| P110010 | 101 |
| P110010 | 105 |
| P110010 | 123 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3.50 mm Stent Diameter | ||
| Device Size Text, specify | 38 mm Stent Length |