PMA P110042S042
- Device
- CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S042
- Product code
- LWS
- Decision date
- 2014-11-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- TO DISPOSITION NON-CONFORMING FEEDTHRUS AT RECEIVING INSPECTION.
Current openFDA PMA Record#
- Device
- CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S042
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-11-25
- Decision code
- OK30
- Date received
- 2014-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO DISPOSITION NON-CONFORMING FEEDTHRUS AT RECEIVING INSPECTION.