POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
FDA premarket approval P880086/S049 · decided 1998-07-14
Approval details
- PMA number
- P880086
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1998-06-30
- Decision date
- 1998-07-14
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer Software Model 3302 Revision C (Paragon Version 1.03).
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