ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P980016/S091 · decided 2006-12-14
Approval details
- PMA number
- P980016
- Supplement
- S091
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-11-28
- Decision date
- 2006-12-14
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE MO16 SRAM PACKAGING FOR THE DEVICE HYBRIDS AND A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATA TO 4 ATA FOR THE ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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