PMA P910077S073
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S073
- Product code
- LWS
- Decision date
- 2007-05-01
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR: 1) A CHANGE TO THE TIME BASE OF THE INDUCTIVE COMMUNICATOR CLOCK AND 2) IMPROVEMENTS TO TELEPHONE DETECTION/DISABLING OF THE CALL-WAITING FEATURE AND IMPROVEMENT OF TELEPHONE DIAL-TONE DETECTION.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S073
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-05-01
- Decision code
- APPR
- Date received
- 2007-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) A CHANGE TO THE TIME BASE OF THE INDUCTIVE COMMUNICATOR CLOCK AND 2) IMPROVEMENTS TO TELEPHONE DETECTION/DISABLING OF THE CALL-WAITING FEATURE AND IMPROVEMENT OF TELEPHONE DIAL-TONE DETECTION.