SELUTE
FDA premarket approval P950001/S016 · decided 2006-05-11
Approval details
- PMA number
- P950001
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELUTE
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2006-04-13
- Decision date
- 2006-05-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
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