PMA P910077S084
- Device
- LATITUDE PACEART INTEGRATION SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S084
- Product code
- LWS
- Decision date
- 2008-03-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE LATITUDE PACEART INTEGRATION (LPI) (MODEL 6472 V1.0) THAT WILL RESIDE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM (MODEL 6488 V4.0).
Current openFDA PMA Record#
- Device
- LATITUDE PACEART INTEGRATION SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S084
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2008-03-17
- Decision code
- APPR
- Date received
- 2008-02-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LATITUDE PACEART INTEGRATION (LPI) (MODEL 6472 V1.0) THAT WILL RESIDE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM (MODEL 6488 V4.0).