PMA P960040S443
- Device
- Implantable Cardioverter Defibrillator (ICD)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S443
- Product code
- LWS
- Decision date
- 2019-10-29
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillator (ICD)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S443
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-10-29
- Decision code
- OK30
- Date received
- 2019-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.