PMA P050046S030
- Device
- ACUITY™ Steerable Heart Failure Lead
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S030
- Product code
- OJX
- Decision date
- 2021-01-13
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Add a new supplier of nitrile gloves, Ansell.
Current openFDA PMA Record#
- Device
- ACUITY™ Steerable Heart Failure Lead
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S030
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- 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.