FORTIFY VR/DR
FDA premarket approval P910023/S239 · decided 2010-09-23
Approval details
- PMA number
- P910023
- Supplement
- S239
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FORTIFY VR/DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-07-22
- Decision date
- 2010-09-23
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE LONGEVITY INFORMATION BASED ON ADDITIONAL BENCH TESTING.
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