PMA P960013
- Device
- Tendril STS Leads; Ultipace Leads; Optisense Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S121
- Product code
- NVN
- Decision date
- 2026-06-26
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- to move a site for a Lead component, Helix Shaft Assembly
Current openFDA PMA Record#
- Device
- Tendril STS Leads; Ultipace Leads; Optisense Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S134
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- 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