PMA P050046S032
- Device
- ACUITY STEERABLE LEAD SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S032
- Product code
- OJX
- Decision date
- 2021-09-24
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Use a new controlled environment area at the Boston Scientific Dorado, Puerto Rico facility.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE LEAD SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S032
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use a new controlled environment area at the Boston Scientific Dorado, Puerto Rico facility.