PMA P910077S051
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S051
- Product code
- LWS
- Decision date
- 2005-09-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM INCLUDING THE MODEL 6482 LATITUDE COMMUNICATOR V1.4 AND THE SUPPLEMENTAL APPLICATION SERVER (SAS) SOFTWARE V1.0.1 FOR USE IN MONITORING PATIENTS IMPLANTED WITH A CONTAK RENEWAL 3 RF.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S051
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2005-09-08
- Decision code
- APPR
- Date received
- 2005-03-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM INCLUDING THE MODEL 6482 LATITUDE COMMUNICATOR V1.4 AND THE SUPPLEMENTAL APPLICATION SERVER (SAS) SOFTWARE V1.0.1 FOR USE IN MONITORING PATIENTS IMPLANTED WITH A CONTAK RENEWAL 3 RF.