MEDTRONIC(R) MODEL 5342 & 5245 PULSE GENERATOR
FDA premarket approval P820003/S061 · decided 1992-06-16
Approval details
- PMA number
- P820003
- Supplement
- S061
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC(R) MODEL 5342 & 5245 PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1991-11-13
- Decision date
- 1992-06-16
- Days to decision
- 216 days
- Decision code
- APPR
- 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.