Philips

Philips

30 products

    a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for its HeartStart OnSite defibrillator [1] and HeartStart Home defibrillator [2], and the relevant supporting accessories, such as batteries and pad electrodes.

     

    Philips’ HeartStart OnSite and HeartStart Home defibrillators are the only over-the-counter automated external defibrillators (AEDs) available to consumers in the US, while the HeartStart Home defibrillator is the only AED specifically indicated for home environments.

     

    “We are committed to delivering high quality, innovative AEDs to provide personalized therapy to victims of sudden cardiac arrest,” said Arman Voskerchyan, Business Leader Therapeutic Care at Philips. “Premarket approval for our HeartStart OnSite and HeartStart Home defibrillators, currently the only over-the-counter AEDs available in the US, reflects the robust work of our teams that delivered the strong and extensive technical, clinical and production data included in the PMA filing for these devices.”

     

    PMA for Philips’ HeartStart OnSite and HeartStart Home defibrillators can be found here. These devices already had FDA 510(k) clearance, but are now subject to PMA.

    30 products
    Sale
    Philips - AED Battery
    Sale price $138.00 Regular price $160.00 Save $22
    Sale
    Philips - Adult SMART Pads cartridge (1 pair)
    Sale price $52.00 Regular price $64.00 Save $12
    Sale
    Philips - HeartStart Standard Carry Case for AED
    Sale price $120.00 Regular price $136.00 Save $16
    Sale
    Philips - HeartStart OnSite AED with Slim Carrying Case
    Sale price $1,317.00 Regular price $1,517.00 Save $200
    Sale
    Philips - HeartStart HOME AED with Slim Carrying Case
    Sale price $1,317.00 Regular price $1,358.00 Save $41
    Sale
    Philips - Infant/Child SMART Pads cartridge (1 pair)
    Sale price $88.00 Regular price $120.00 Save $32
    Sale
    Philips - HeartStart OnSite AED - English
    Sale price $1,286.00 Regular price $1,438.00 Save $152
    Sale
    Philips - Manual, Owner's - HeartStart Home - English
    Sale price $13.00 Regular price $21.00 Save $8
    Sale
    Philips - Manual, Instructions for Use - HeartStart OnSite - English
    Sale price $25.00 Regular price $40.00 Save $15
    Sale
    Philips - Manikin - External (metallic strips) Adapters (5)
    Sale price $56.00 Regular price $72.00 Save $16
    Sale
    Philips - Manikin - Internal Adapter (1)
    Sale price $40.00 Regular price $56.00 Save $16
    Sale
    Philips - Training Pads cartridge (1 pair) - Pediatric
    Sale price $71.00 Regular price $96.00 Save $25
    Sale
    Philips - Replacement Training Pads (1 pair) - Adult (no cartridge)
    Sale price $28.00 Regular price $40.00 Save $12
    Sale
    Philips - Heartstart Plastic Waterproof Carry Case for AED
    Sale price $185.00 Regular price $224.00 Save $39
    Sale
    Philips - Manual, Instructions for Use - HeartStart Home - English
    Sale price $25.00 Regular price $40.00 Save $15
    Sale
    Philips - Quick Reference Guide - HS1 - French
    Sale price $7.00 Regular price $9.00 Save $2
    Sale
    Philips - Quick Reference Guide - HS1 - English
    Sale price $7.00 Regular price $9.00 Save $2
    Sale
    Philips - Manual, Instructions for Use - HeartStart OnSite - French
    Sale price $25.00 Regular price $40.00 Save $15
    Sale
    Philips - DVD/CD - Instructor’s Tool Kit - English
    Sale price $42.00 Regular price $64.00 Save $22
    Sale
    Philips - Replacement carrying case for HeartStart OnSite Trainer
    Sale price $31.00 Regular price $48.00 Save $17
    Sale
    Philips - Pads Placement Guide (Flat child) - Pediatric
    Sale price $24.00 Regular price $40.00 Save $16
    Sale
    Philips - Pads Placement Guide (Flat man) - Adult
    Sale price $31.00 Regular price $48.00 Save $17
    Sale
    Philips - Training Pads cartridge (1 pair) - Adult
    Sale price $67.00 Regular price $80.00 Save $13
    Sale
    Philips - Instructions for use for HeartStart OnSite Trainer
    Sale price $12.00 Regular price $16.00 Save $4
    Sale
    Philips - HeartStart OnSite Trainer - English
    Sale price $286.00 Regular price $320.00 Save $34
    Sale
    Philips - HeartStart Slim Carry Case for AED
    Sale price $120.00 Regular price $136.00 Save $16
    Sale
    Philips - Fast Response Kit
    Sale price $47.00 Regular price $56.00 Save $9