MEDTRONIC(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD,
FDA premarket approval P890003/S039 · decided 1996-03-22
Approval details
- PMA number
- P890003
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD,
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1995-04-20
- Decision date
- 1996-03-22
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC THERA VDD MODEL 8968I AND PRODIGY VDD MODEL 8168 PULSE GENERATORS, MODEL 5032 CAPSURE VDD LEAD, MODEL 9879E SOFTWARE, AND MODEL 9759 MEMORYMOD
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