PMA P050046S016
- Device
- ACUITY STEERALE LEADS MODELS: 4554, 4555
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S016
- Product code
- NVY
- Decision date
- 2012-10-03
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
Current openFDA PMA Record#
- Device
- ACUITY STEERALE LEADS MODELS: 4554, 4555
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S016
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2012-10-03
- Decision code
- OK30
- Date received
- 2012-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.