PMA P050046S018
- Device
- ACUITY STEERABLE HEART FAILURE LEAD FAMILY
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S018
- Product code
- NVY
- Decision date
- 2012-12-05
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE HEART FAILURE LEAD FAMILY
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S018
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2012-12-05
- Decision code
- OK30
- Date received
- 2012-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE TRACEABILITY AND TRACKING SYSTEM.