PMA P050046S013
- Device
- ACUITY STEERABLE IS-1 LEADS
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S013
- Product code
- NVY
- Decision date
- 2012-02-29
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE IS-1 LEADS
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S013
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2012-02-29
- Decision code
- OK30
- Date received
- 2012-01-24
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.