PMA P050046S011
- Device
- ACUITY LEADS
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S011
- Product code
- NVY
- Decision date
- 2011-06-17
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
Current openFDA PMA Record#
- Device
- ACUITY LEADS
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S011
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2011-06-17
- Decision code
- OK30
- Date received
- 2011-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.