PMA P960013S108
- Device
- Tendril ST/STS Steroid Eluting Cardiac Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S108
- Product code
- NVN
- Decision date
- 2019-10-25
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Approval to update the in vitro elution methods.
Current openFDA PMA Record#
- Device
- Tendril ST/STS Steroid Eluting Cardiac Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S108
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-10-25
- Decision code
- APPR
- Date received
- 2019-07-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to update the in vitro elution methods.