PMA P960013S080
- Device
- Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S080
- Product code
- NVN
- Decision date
- 2016-04-28
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Alternate supplier for the lead connector boot.
Current openFDA PMA Record#
- Device
- Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S080
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2016-04-28
- Decision code
- OK30
- Date received
- 2016-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the lead connector boot.