PMA P960013S061
- Device
- TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S061
- Product code
- NVN
- Decision date
- 2015-08-13
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
Current openFDA PMA Record#
- Device
- TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S061
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2015-08-13
- Decision code
- APPR
- Date received
- 2010-05-20
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.