HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS
FDA premarket approval P160029/S026 · decided 2024-12-12
Approval details
- PMA number
- P160029
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS
- Generic name
- Over-the-counter automated external defibrillator
- Applicant
- Philips Medical Systems, Inc.
- Date received
- 2024-09-13
- Decision date
- 2024-12-12
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NSA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- material change to pads
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PCR ELEVA 1.2 (K093355) | Philips Medical Systems, Inc. | 2010-01-08 |
| PINNACLE3 SMARTARC (K090808) | Philips Medical Systems, Inc. | 2009-04-03 |
| PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391) | Philips Medical Systems, Inc. | 2007-09-07 |
| PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783) | Philips Medical Systems, Inc. | 2007-04-27 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741) | Philips Medical Systems, Inc. | 2004-07-21 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN (K040955) | Philips Medical Systems, Inc. | 2004-05-12 |
| HEARTSTART MRX, MODEL M3535A (K040404) | Philips Medical Systems, Inc. | 2004-05-04 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II (K040357) | Philips Medical Systems, Inc. | 2004-03-03 |