BYREL PROGRAMABLE PACEMAKER
FDA premarket approval P780009 · decided 1979-03-27
Approval details
- PMA number
- P780009
- Trade name
- BYREL PROGRAMABLE PACEMAKER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1978-11-20
- Decision date
- 1979-03-27
- Days to decision
- 127 days
- Decision code
- APWD
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.