PMA P110042S026
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S026
- Product code
- LWS
- Decision date
- 2014-02-07
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- IMPLEMENT A HIGH POWER HYBRID (HPH) RESISTANCE SCREENING SYSTEM AND REWORK PROCESS AT THE HPH SUPPLIER.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S026
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-02-07
- Decision code
- OK30
- Date received
- 2014-01-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENT A HIGH POWER HYBRID (HPH) RESISTANCE SCREENING SYSTEM AND REWORK PROCESS AT THE HPH SUPPLIER.