PMA P910073S158
- Device
- ENDOTAK LEAD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S158
- Product code
- LWS
- Decision date
- 2020-12-04
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Labeling updates to the clinical study summary for the post approval study.
Current openFDA PMA Record#
- Device
- ENDOTAK LEAD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S158
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-12-04
- Decision code
- APPR
- Date received
- 2020-10-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Labeling updates to the clinical study summary for the post approval study.