PMA P960013S132
- Device
- Tendril STS Leads; Ultipace Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S132
- Product code
- NVN
- Decision date
- 2025-12-09
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- to move a supplier's manufacturing site for implantable lead subcomponents
Current openFDA PMA Record#
- Device
- Tendril STS Leads; Ultipace Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S132
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2025-12-09
- Decision code
- OK30
- Date received
- 2025-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to move a supplier's manufacturing site for implantable lead subcomponents