PMA P050046S009
- Device
- ACUITY STEERABLE STYLET ACCESSORY
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S009
- Product code
- NVY
- Decision date
- 2011-06-29
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- APPROVAL FOR ACCEPTANCE OF A CHANGE TO RELOCATE A SENSOR ON WIRE GRINDING EQUIPMENT AND FORMALIZE INSPECTIONS AS ACCEPTANCE ACTIVITIES.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE STYLET ACCESSORY
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S009
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2011-06-29
- Decision code
- APPR
- Date received
- 2011-01-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ACCEPTANCE OF A CHANGE TO RELOCATE A SENSOR ON WIRE GRINDING EQUIPMENT AND FORMALIZE INSPECTIONS AS ACCEPTANCE ACTIVITIES.