FDA UDI
In Commercial Distribution
🇺🇸 United States
Innova™ Vascular
DI: 08714729873686
·
Model: H74939293061570
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Innova™ Vascular
- Primary DI
- 08714729873686
- Version / Model
- H74939293061570
- Catalog Number
- H74939293061570
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-17
- Public Version
- 8
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- e5703e5a-e424-4cea-86e9-ab900cf28c6f
Device Description
Self-Expanding Stent System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| NIP | STENT, SUPERFICIAL FEMORAL ARTERY | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47932 | Peripheral artery stent, bare-metal | A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729873686 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140028 | 000 |
| P140028 | 010 |
| P140028 | 036 |
| P140028 | 053 |
| P140028 | 070 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 75 cm Effective Length | ||
| Device Size Text, specify | 150 mm Stent Length | ||
| Device Size Text, specify | 6 mm Stent Diameter |