PMA P050046S025
- Device
- ACUITY STEERABLE LEAD
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S025
- Product code
- OJX
- Decision date
- 2015-06-30
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- CHANGE TO THE INTERNAL INSPECTION REQUIREMENTS FOR MOISTURE CONTENT OF THE TWO PART MEDICAL ADHESIVE.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE LEAD
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S025
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2015-06-30
- Decision code
- OK30
- Date received
- 2015-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE INTERNAL INSPECTION REQUIREMENTS FOR MOISTURE CONTENT OF THE TWO PART MEDICAL ADHESIVE.