IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS
FDA premarket approval P880086/S110 · decided 2006-01-31
Approval details
- PMA number
- P880086
- Supplement
- S110
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-10-07
- Decision date
- 2006-01-31
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR AN ALTERNATE ORGANIC FEEDTHRU SUBSTRATE TO BE USED IN THE AFFINITY, ENTITY, IDENTITY, IDENTITY ADX, INTEGRITY AND VERITY FAMILIES OF PULSE GENERATORS.
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