PMA P110042S016
- Device
- SUBCUTANEOUS IMPLANABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S016
- Product code
- LWS
- Decision date
- 2013-10-31
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR A SUPPLIER CHANGE FOR THE HIGH VOLTAGE CAPACITORS USED IN THE S-ICD SYSTEM.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANABLE DEFIBRILLATOR S-ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S016
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-10-31
- Decision code
- APPR
- Date received
- 2013-09-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A SUPPLIER CHANGE FOR THE HIGH VOLTAGE CAPACITORS USED IN THE S-ICD SYSTEM.