PMA P050046S017
- Device
- ACUITY STEERABLE FAMILY OF LV PACING LEADS
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S017
- Product code
- NVY
- Decision date
- 2012-11-09
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE FAMILY OF LV PACING LEADS
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S017
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2012-11-09
- Decision code
- OK30
- Date received
- 2012-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.