DURATA, DURATA DF4
FDA premarket approval P950022/S084 · decided 2012-10-10
Approval details
- PMA number
- P950022
- Supplement
- S084
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURATA, DURATA DF4
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-09-13
- Decision date
- 2012-10-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
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