PMA P910077S078
- Device
- ZOOM LATITUDE PROGRAMMING SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S078
- Product code
- LWS
- Decision date
- 2007-10-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR LEAKAGE CURRENT RE-CLASSIFICATION FROM CF TO BF AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.
Current openFDA PMA Record#
- Device
- ZOOM LATITUDE PROGRAMMING SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S078
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-10-18
- Decision code
- APPR
- Date received
- 2007-09-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR LEAKAGE CURRENT RE-CLASSIFICATION FROM CF TO BF AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.