PMA P960013S078
- Device
- TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S078
- Product code
- NVN
- Decision date
- 2016-04-28
- 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
- Approval for the reassessment of microbiological levels for cleanrooms.
Current openFDA PMA Record#
- Device
- TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S078
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2016-04-28
- Decision code
- APPR
- Date received
- 2015-10-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the reassessment of microbiological levels for cleanrooms.