PMA P110042S007
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S007
- Product code
- LWS
- Decision date
- 2013-04-30
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER OF THE LOW POWER HYBRID (LPH) ASSEMBLY OF THE S-ICD® SYSTEM, INCLUDING NEW COMPONENTS FOR THE LPH.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S007
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-04-30
- Decision code
- APPR
- Date received
- 2013-04-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER OF THE LOW POWER HYBRID (LPH) ASSEMBLY OF THE S-ICD® SYSTEM, INCLUDING NEW COMPONENTS FOR THE LPH.