PMA P110042S015
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S015
- Product code
- LWS
- Decision date
- 2013-09-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- EXPAND RECEIVING AND INSPECTION ACTIVITIES FOR CERTAIN S-ICD® COMPONENTS AND ACCESSORIES TO BOSTON SCIENTIFIC¿S FACILITY LOCATED IN ST. PAUL, MINNESOTA.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S015
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-09-25
- Decision code
- OK30
- Date received
- 2013-08-30
- Supplement type
- 30-Day Notice
- Approval order statement
- EXPAND RECEIVING AND INSPECTION ACTIVITIES FOR CERTAIN S-ICD® COMPONENTS AND ACCESSORIES TO BOSTON SCIENTIFIC¿S FACILITY LOCATED IN ST. PAUL, MINNESOTA.