PMA P950022S134
- Device
- Durata And Optisure HV Passive Steroid Eluting Cardiac Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S134
- Product code
- LWS
- Decision date
- 2020-06-30
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Implement previously approved changes to new lead models Durata (7172Q) and Optisure (LDP210Q).
Current openFDA PMA Record#
- Device
- Durata And Optisure HV Passive Steroid Eluting Cardiac Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S134
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-06-30
- Decision code
- OK30
- Date received
- 2020-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement previously approved changes to new lead models Durata (7172Q) and Optisure (LDP210Q).