Identity
- Trade Name
- 23MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM FDA UDI
- Generic Name
- Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
- Model / Reference
- 9355FS23 FDA UDI
Identifiers
- Catalog Number
- 9355FS23A FDA UDI
- Primary DI / UDI-DI
- 00690103193220 FDA UDI
- PMA Number
- P130009 FDA UDI
- FDA Product Code
- NPT FDA UDI
- GMDN Term
- Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
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
Category: Aortic transcatheter heart valve bioprosthesis, stent-like framework
23mm X 3cm X 105cm Novaflex+ Delivery System by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic transcatheter heart valve bioprosthesis, stent-like framework.
- Evolut™ FX — Medtronic Core Valve, LLC · Class III
- EnVeo™ PRO — MEDTRONIC, INC. · Class III
- CoreValve™ Evolut™ PRO — Medtronic Core Valve, LLC · Class III
- EnVeo™ R — Medtronic Core Valve, LLC · Class III
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC · Class III
- Evolut™ PRO+ — Medtronic Core Valve, LLC · Class III
- Evolut™ FX — Medtronic Core Valve, LLC · Class III
- Evolut™ PRO+ — Medtronic Core Valve, LLC · Class III
Cleared under the same submission
P130009 also covers:
- 16F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- 18F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- 20F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- 23MM X 29MM X 55CM ASCENDRA+ DELIVERY SYSTEM — Edwards Lifesciences LLC
- 24F (7.9MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- 24F (7.9MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- 26F (8.6MM) X 25CM ASCENDRA+ INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- 26MM X 29MM X 55CM ASCENDRA+ DELIVERY SYSTEM — Edwards Lifesciences LLC
- 26MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM — Edwards Lifesciences LLC
- 29MM X 3.4CM X 105CM NOVAFLEX+ DELIVERY SYSTEM — Edwards Lifesciences LLC
- 29MM X 33MM X 55CM ASCENDRA+ DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS CRIMPER — Edwards Lifesciences LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 759ff5bc-a41f-4a8a-a04f-c10061ff19a9 34 fields · synced Jun 8, 2026