PMA P050046S002
- Device
- ACUITY STEERABLE LEAD
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S002
- Product code
- NVY
- Decision date
- 2008-03-05
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- APPROVAL FOR A SPECIFICATION CHANGE FOR ACCEPTANCE OF SILICONE TUBING USED TO MANUFACTURE ACUITY STEERABLE LEADS.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE LEAD
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S002
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2008-03-05
- Decision code
- APPR
- Date received
- 2007-11-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A SPECIFICATION CHANGE FOR ACCEPTANCE OF SILICONE TUBING USED TO MANUFACTURE ACUITY STEERABLE LEADS.