PMA P110042S014
- Device
- CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S014
- Product code
- LWS
- Decision date
- 2013-09-27
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR TWO ALTERNATE SILICON CAPACITORS USED ON THE LOW POWER HYBRID ASSEMBLY FOR THE S-ICD SYSTEM.
Current openFDA PMA Record#
- Device
- CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S014
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-09-27
- Decision code
- APPR
- Date received
- 2013-08-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO ALTERNATE SILICON CAPACITORS USED ON THE LOW POWER HYBRID ASSEMBLY FOR THE S-ICD SYSTEM.