- Device
- TENDRIL/TENDRIL ST & STS/OPTISENSE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S055
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2011-05-11
- Decision code
- APPR
- Date received
- 2009-11-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.