PMA P110042S050
- Device
- EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S050
- Product code
- LWS
- Decision date
- 2015-10-07
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- MANUFACTURE THE SPRING CONNECTOR BLOCK HOUSING COMPONENTS FOR THE REFERENCED PULSE GENERATORS AT BOSTON SCIENTIFIC CORPORATION FACILITY, ST. PAUL, MN
Current openFDA PMA Record#
- Device
- EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S050
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-10-07
- Decision code
- OK30
- Date received
- 2015-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURE THE SPRING CONNECTOR BLOCK HOUSING COMPONENTS FOR THE REFERENCED PULSE GENERATORS AT BOSTON SCIENTIFIC CORPORATION FACILITY, ST. PAUL, MN