PMA P960013S072
- Device
- TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S072
- Product code
- NVN
- Decision date
- 2012-05-03
- 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
- IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
Current openFDA PMA Record#
- Device
- TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S072
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2012-05-03
- Decision code
- OK30
- Date received
- 2012-04-03
- Supplement type
- 30-Day Notice
- Approval order statement
- IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.