PMA P960040S394
- Device
- Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D0
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S394
- Product code
- LWS
- Decision date
- 2017-06-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Updates to the torque and final pack electrical test software.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D0
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S394
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-06-21
- Decision code
- OK30
- Date received
- 2017-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the torque and final pack electrical test software.