PMA P960006S050
- Device
- FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S050
- Product code
- NVN
- Decision date
- 2021-01-13
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Add a new supplier of nitrile gloves, Ansell.
Current openFDA PMA Record#
- Device
- FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S050
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-01-13
- Decision code
- OK30
- Date received
- 2021-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new supplier of nitrile gloves, Ansell.