PMA P110042S025
- Device
- CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S025
- Product code
- LWS
- Decision date
- 2014-01-31
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- USE OF A TWO-PART EPOXY ON THE HIGH VOLTAGE CAPACITOR USED IN THE S-ICD SYSTEM.
Current openFDA PMA Record#
- Device
- CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S025
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-01-31
- Decision code
- OK30
- Date received
- 2014-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A TWO-PART EPOXY ON THE HIGH VOLTAGE CAPACITOR USED IN THE S-ICD SYSTEM.