MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
FDA premarket approval P890003/S057 · decided 1998-07-14
Approval details
- PMA number
- P890003
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1998-06-12
- Decision date
- 1998-07-14
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Requested a change in the application pattern of the epoxy area that affixes the device battery to the insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
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