PMA P910077S094
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S094
- Product code
- LWS
- Decision date
- 2009-07-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL OF A SOFTWARE MAINTENANCE RELEASE (SMR) FOR THE LATITUDE SYSTEM SERVER SOFTWARE, V5.0.6, MODEL 6488.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S094
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2009-07-21
- Decision code
- APPR
- Date received
- 2009-05-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF A SOFTWARE MAINTENANCE RELEASE (SMR) FOR THE LATITUDE SYSTEM SERVER SOFTWARE, V5.0.6, MODEL 6488.