PMA P960013S047
- Device
- TENDRIL/TENDRIL ST/OPTISENSE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S047
- Product code
- NVN
- Decision date
- 2009-07-10
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- THREE STERILIZATION CHANGES.
Current openFDA PMA Record#
- Device
- TENDRIL/TENDRIL ST/OPTISENSE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S047
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2009-07-10
- Decision code
- OK30
- Date received
- 2009-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THREE STERILIZATION CHANGES.