PMA P910073S146
- Device
- Lead Cap Kit (model 7007)
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S146
- Product code
- LWS
- Decision date
- 2018-04-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for a new S-ICD kit of tunneling tools, called EMBLEM S-ICD Electrode Delivery System (EDS), Model 4712.
Current openFDA PMA Record#
- Device
- Lead Cap Kit (model 7007)
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S146
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-04-19
- Decision code
- APPR
- Date received
- 2017-12-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new S-ICD kit of tunneling tools, called EMBLEM S-ICD Electrode Delivery System (EDS), Model 4712.