Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ACUITY STEERALE LEADS MODELS: 4554, 4555
• Generic Name: Permanent defibrillator electrodes
• Applicant: Guidant Corp.; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P050046
• Supplement Number: S016
• Date Received: 09/04/2012
• Decision Date: 10/03/2012
• Product Code: NVY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.