PMA P910077S071
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S071
- Product code
- LWS
- Decision date
- 2007-03-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S071
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-03-28
- Decision code
- APPR
- Date received
- 2007-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.