DURATA, RIATA ST OPTIM, RIATA ST, RIATA SF
FDA premarket approval P950022/S053 · decided 2008-06-09
Approval details
- PMA number
- P950022
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURATA, RIATA ST OPTIM, RIATA ST, RIATA SF
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-05-21
- Decision date
- 2008-06-09
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
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