FDA PMA Number P160029, HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Request: Minutes and slides from any pre-submission meeting between FDA adn MED-EL related to the approval of P000025/S104, which was a PMA supplement for indication changes submitted by MED-EL.
PMA Number: P160029
Device: HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Generic Name: Over-the-counter automated external defibrillator
Manufacturer: PHILIPS MEDICAL SYSTEMS, INC.
Product Code:
Date Received: 07/29/2016
Decision Date: 06/06/2019
Notice Date: 07/02/2019