PMA P960013S094
- Device
- Tendril and Optisense f Low Voltage Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S094
- Product code
- NVN
- Decision date
- 2018-02-08
- 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
- Minor manufacturing changes to the polyvinylpyrrolidone coating process.
Current openFDA PMA Record#
- Device
- Tendril and Optisense f Low Voltage Leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S094
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-02-08
- Decision code
- OK30
- Date received
- 2018-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor manufacturing changes to the polyvinylpyrrolidone coating process.