- Device
- PASSIVE PLUS AND IOSFLEX LEAD FAMILIES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960030
- Supplement
- S035
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2012-04-13
- Decision code
- APPR
- Date received
- 2012-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE CONNECTOR BOOT ON THE ISOFLEX MODELS, ISOFLEX OPTIM MODELS 1944 AND 1948.