PMA P950022S154
- Device
- Durata Leads; Optisure Leads; UltiSync Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S154
- Product code
- LWS
- Decision date
- 2026-06-26
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- to move a site for a Lead component, Helix Shaft Assembly
Current openFDA PMA Record#
- Device
- Durata Leads; Optisure Leads; UltiSync Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S154
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-06-26
- Decision code
- OK30
- Date received
- 2026-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to move a site for a Lead component, Helix Shaft Assembly