PMA P950022S152
- Device
- Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S152
- Product code
- LWS
- Decision date
- 2026-04-24
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- tooling changes and added in-process inspections for lead manufacturing
Current openFDA PMA Record#
- Device
- Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S152
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-24
- Decision code
- OK30
- Date received
- 2026-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- tooling changes and added in-process inspections for lead manufacturing