PMA P910077S080
- Device
- LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S080
- Product code
- LWS
- Decision date
- 2007-11-14
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- REPLACEMENT OF THE DEPANELIZATION EQUIPMENT AND ENHANCEMENT OF A VISUAL INSPECTION FOR THE DAUGHTER BOARD OF THE DEVICE.
Current openFDA PMA Record#
- Device
- LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S080
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-11-14
- Decision code
- OK30
- Date received
- 2007-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF THE DEPANELIZATION EQUIPMENT AND ENHANCEMENT OF A VISUAL INSPECTION FOR THE DAUGHTER BOARD OF THE DEVICE.