PMA P910077S074
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S074
- Product code
- LWS
- Decision date
- 2007-06-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order 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.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S074
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-06-15
- Decision code
- APPR
- Date received
- 2007-02-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.