AFFINITY PULSE GENERATORS
FDA premarket approval P880086/S075 · decided 2000-08-15
Approval details
- PMA number
- P880086
- Supplement
- S075
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-08-01
- Decision date
- 2000-08-15
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR REMOVAL OF THE PARYLENE COATING FROM THE AFFINITY MODELS DR 5330, SR 5130, DC 5230, ENTITY DR 5326, AND ENTITY DC 5226 PULSE GENERATORS.
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