PMA P050046S031
- Device
- ACUITY Steerable Lead System
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S031
- Product code
- OJX
- Decision date
- 2021-04-02
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.
Current openFDA PMA Record#
- Device
- ACUITY Steerable Lead System
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S031
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2021-04-02
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.