Identity
- Trade Name
- AdVance™ EUDAMEDAdVance™ XP FDA UDI
- Generic Name
- Male stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
- Device Name
- AdVance XP Male Sling System EUDAMEDMale Sling System FDA UDI
- Model / Reference
- 720163-01 EUDAMEDFDA UDI
- Description
- Male Sling System FDA UDI
Identifiers
- Catalog Number
- 720163-01 FDA UDI
- Primary DI / UDI-DI
- 00878953005560 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000046MQ EUDAMED
- FDA Product Code
- OTM FDA UDI
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Male stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Medical Purpose
- Male Sling System EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
AdVance™ by Boston Scientific Corporation — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000046MQ | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-PR-000008885
Sources (2)
- EUDAMED c7bdc4fc-d453-4214-a066-6dfed41c56ea 61 fields · synced Jun 19, 2026
- FDA UDI 4e8e5582-4f39-4cb2-8468-1ef1b06415b4 34 fields · synced May 30, 2026