PMA P160029S027
- Device
- HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S027
- Product code
- NSA
- Decision date
- 2025-06-09
- Classification
- Cardiovascular
- Generic name
- Over-the-counter automated external defibrillator
- Approval order statement
- a sub-tier supplier manufacturing site change for PCA resistors
Current openFDA PMA Record#
- Device
- HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S027
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2025-06-09
- Decision code
- OK30
- Date received
- 2025-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a sub-tier supplier manufacturing site change for PCA resistors