BYREL PROGRAMABLE PACEMAKER
FDA premarket approval P780009/S001 · decided 1981-07-21
Approval details
- PMA number
- P780009
- Supplement
- S001
- Trade name
- BYREL PROGRAMABLE PACEMAKER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1981-06-12
- Decision date
- 1981-07-21
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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