PMA P110042S034
- Device
- CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S034
- Product code
- LWS
- Decision date
- 2014-05-29
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADD A DROPOUT VOLTAGE VARIATION TEST IN THE MANUFACTURING PROCESS FOR THE S-ICD PULSE GENERATOR.
Current openFDA PMA Record#
- Device
- CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S034
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-05-29
- Decision code
- OK30
- Date received
- 2014-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A DROPOUT VOLTAGE VARIATION TEST IN THE MANUFACTURING PROCESS FOR THE S-ICD PULSE GENERATOR.