PMA P960013S102
- Device
- Tendrill SDX, OptiSense, Tendrill STS, Tendril ST.
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S102
- Product code
- NVN
- Decision date
- 2018-11-07
- 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
- Reduce solvents analytical testing at release from a per batch basis to periodic testing.
Current openFDA PMA Record#
- Device
- Tendrill SDX, OptiSense, Tendrill STS, Tendril ST.
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S102
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-11-07
- Decision code
- OK30
- Date received
- 2018-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce solvents analytical testing at release from a per batch basis to periodic testing.