PMA P910077S062
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6482
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S062
- Product code
- LWS
- Decision date
- 2006-06-23
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL TO MODIFY THE INSTRUCTIONS FOR THE LATITUDE CLINICIAN MANUAL.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6482
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S062
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2006-06-23
- Decision code
- APPR
- Date received
- 2006-05-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO MODIFY THE INSTRUCTIONS FOR THE LATITUDE CLINICIAN MANUAL.