PMA P960030S052
- Device
- IsoFlex Optim Leads (lV Passive)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960030
- Supplement
- S052
- Product code
- NVN
- Decision date
- 2018-04-02
- 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 an alternate supplier for material used for lead insulation tubing.
Current openFDA PMA Record#
- Device
- IsoFlex Optim Leads (lV Passive)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960030
- Supplement
- S052
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-04-02
- Decision code
- APPR
- Date received
- 2017-02-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate supplier for material used for lead insulation tubing.