PMA P910077S109
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6.
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S109
- Product code
- LWS
- Decision date
- 2010-11-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481).
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6.
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S109
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2010-11-19
- Decision code
- APPR
- Date received
- 2010-09-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481).