MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
FDA premarket approval P890003/S055 · decided 1998-08-12
Approval details
- PMA number
- P890003
- Supplement
- S055
- Trade name
- MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1998-04-20
- Decision date
- 1998-08-12
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc.,(MPRI), Road 149, Rm. 56.3, Vilalba, Puerto Rico 00755.
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