PMA P910077S097
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S097
- Product code
- LWS
- Decision date
- 2009-11-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM G2 RF COMMUNICATOR MODEL 6476 SOFTWARE, VERSION 3.02 AND LATITUDE PATIENT MANAGEMENT SERVER MODEL 6488, VERSION 5.2.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S097
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2009-11-25
- Decision code
- APPR
- Date received
- 2009-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM G2 RF COMMUNICATOR MODEL 6476 SOFTWARE, VERSION 3.02 AND LATITUDE PATIENT MANAGEMENT SERVER MODEL 6488, VERSION 5.2.