PMA P950022S132
- Device
- Durata HV Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S132
- Product code
- LWS
- Decision date
- 2020-06-04
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval to include long-term safety and effectiveness data from the Cardiac Lead Assessment Study in the device labeling.
Current openFDA PMA Record#
- Device
- Durata HV Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S132
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-06-04
- Decision code
- APPR
- Date received
- 2020-05-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to include long-term safety and effectiveness data from the Cardiac Lead Assessment Study in the device labeling.