PMA P110042S056
- Device
- SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S056
- Product code
- LWS
- Decision date
- 2015-12-09
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- TO IMPLEMENT A NEW FIXTURE FOR AN ELECTRICAL TEST AND TO RE-POSITION A VISUAL INSPECTION STEP TO AFTER ELECTRICAL TESTING.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S056
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-12-09
- Decision code
- OK30
- Date received
- 2015-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO IMPLEMENT A NEW FIXTURE FOR AN ELECTRICAL TEST AND TO RE-POSITION A VISUAL INSPECTION STEP TO AFTER ELECTRICAL TESTING.