PMA P960013S095
- Device
- Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S095
- Product code
- NVN
- Decision date
- 2018-02-22
- 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
- Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.
Current openFDA PMA Record#
- Device
- Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S095
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-02-22
- Decision code
- OK30
- Date received
- 2018-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.