CURRENT, CURRENT+, CURRENT ACCEL AND FORTIFY CRT-D'S
FDA premarket approval P910023/S232 · decided 2010-06-22
Approval details
- PMA number
- P910023
- Supplement
- S232
- Supplement type
- Real-Time Process
- Trade name
- CURRENT, CURRENT+, CURRENT ACCEL AND FORTIFY CRT-D'S
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-04-30
- Decision date
- 2010-06-22
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
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