Identity
- Trade Name
- AMS 700 LGX MS Pump FDA UDI
- Generic Name
- Inflatable penile prosthesis FDA UDI
- Device Name
- Inflatable Penile Prosthesis, Preconnected 1 Pump to 2 Cylinders, Infrapubic FDA UDI
- Model / Reference
- 72404307 FDA UDI
- Description
- Inflatable Penile Prosthesis, Preconnected 1 Pump to 2 Cylinders, Infrapubic FDA UDI
Identifiers
- Catalog Number
- 72404307 FDA UDI
- Primary DI / UDI-DI
- 00878953005775 FDA UDI
- FDA Product Code
- JCW FDA UDI
- GMDN Term
- Inflatable penile prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 18 Centimeter FDA UDIOuter Diameter — 12 Millimeter FDA UDI
Category: Inflatable penile prosthesis
The AMS 700 LGX MS Pump is a FDA-cleared, inflatable penile prosthesis designed for men with erectile dysfunction (ED). This premium device offers selective penile tumescence and rigidity, enabling improved vaginal intercourse. With its innovative design and advanced technology, this pump has been engineered to provide optimal performance and comfort.
Similar devices
Also classified as Inflatable penile prosthesis.
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan Classic — Coloplast A/S · Class III
- Titan® — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
- Titan — Coloplast A/S · Class III
Cleared under the same submission
N970012 also covers:
- AMS 700 Accessory Kit — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
- AMS 700 CX MS Pump — Boston Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 338d8951-feb5-4c92-b0c9-e6429df42c99 36 fields · synced Jul 6, 2026