LATITUDE PATIENT MANAGEMENT SYSTEM
FDA premarket approval P910077/S074 · decided 2007-06-15
Approval details
- PMA number
- P910077
- Supplement
- S074
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-02-23
- Decision date
- 2007-06-15
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MODEL 6482 RT COMMUNICATOR FOR USE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM. THE MODIFICATIONS INCLUDE A SOFTWARE UPGRADE (VERSION 1.7.0) AND CHANGES TO THE HARDWARE TO INCREASE RF TRANSMIT POWER.
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