PMA P110042S009
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S009
- Product code
- LWS
- Decision date
- 2013-08-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MODEL 3200 Q-TECH PROGRAMMER TO BE USED WITH SQ-RX® PULSE GENERATOR (MODEL 1010) OF THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD®) SYSTEM ONLY.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S009
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-08-28
- Decision code
- APPR
- Date received
- 2013-06-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 3200 Q-TECH PROGRAMMER TO BE USED WITH SQ-RX® PULSE GENERATOR (MODEL 1010) OF THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD®) SYSTEM ONLY.