PMA P950022S131
- Device
- Optisure High Voltage Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S131
- Product code
- LWS
- Decision date
- 2020-05-15
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) and to discontinue the Externalization and Abrasion sub-study.
Current openFDA PMA Record#
- Device
- Optisure High Voltage Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S131
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-05-15
- Decision code
- APPR
- Date received
- 2020-03-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) and to discontinue the Externalization and Abrasion sub-study.