PMA P960013S077
- Device
- TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S077
- Product code
- NVN
- Decision date
- 2015-09-03
- 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
- USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
Current openFDA PMA Record#
- Device
- TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S077
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2015-09-03
- Decision code
- OK30
- Date received
- 2015-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.