PMA P910077S091
- Device
- LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S091
- Product code
- LWS
- Decision date
- 2008-09-05
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR CHANGES TO THE LATITUDE REGULATED APPLICATION SOFTWARE ON LATITUDE SYSTEM SERVER (MODEL 6488, VERSION 5.0).
Current openFDA PMA Record#
- Device
- LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S091
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2008-09-05
- Decision code
- APPR
- Date received
- 2008-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE LATITUDE REGULATED APPLICATION SOFTWARE ON LATITUDE SYSTEM SERVER (MODEL 6488, VERSION 5.0).