EXTERNAL PULSE GENERATOR
FDA premarket approval P820003/S074 · decided 1999-09-01
Approval details
- PMA number
- P820003
- Supplement
- S074
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXTERNAL PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-07-19
- Decision date
- 1999-09-01
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for labeling changes for the Model 5388 External Pulse Generator.
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