PMA P910077S090
- Device
- LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S090
- Product code
- LWS
- Decision date
- 2008-11-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.
Current openFDA PMA Record#
- Device
- LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S090
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2008-11-17
- Decision code
- APPR
- Date received
- 2008-07-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.