Identity
- Trade Name
- LATITUDE™ Programming System FDA UDI
- Generic Name
- Cardiac pulse generator programmer FDA UDI
- Device Name
- Programming System FDA UDI
- Model / Reference
- 3300 FDA UDI
- Description
- Programming System FDA UDI
Identifiers
- Catalog Number
- 3300 FDA UDI
- Primary DI / UDI-DI
- 00802526616105 FDA UDI
- PMA Number
- P910077 FDA UDI
- FDA Product Code
- OSR FDA UDI
- GMDN Term
- Cardiac pulse generator programmer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Cardiac pulse generator programmer
LATITUDE™ Programming System by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P910077 also covers:
- LATITUDE Consult ™ Power Supply — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE® — Boston Scientific
- LATITUDE® — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
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
- Boston Scientific
Sources (1)
- FDA UDI 2fddbdc1-c0d6-4b1c-a614-8de9756fe1d5 35 fields · synced May 30, 2026