Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
FDA premarket approval P860026/S009 · decided 2019-11-04
Approval details
- PMA number
- P860026
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Applicant
- Avery Biomedical Devices, Inc.
- Date received
- 2017-09-27
- Decision date
- 2019-11-04
- Days to decision
- 768 days
- Decision code
- APPR
- Product code
- GZE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Commack, NY
- Statement
- Approval to replace the Mark IV transmitter with the digital Spirit transmitter.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.