STELID II BFT/BJF/STELIX BR/STELIX II BRF
FDA premarket approval P020030/S009 · decided 2012-02-16
Approval details
- PMA number
- P020030
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Trade name
- STELID II BFT/BJF/STELIX BR/STELIX II BRF
- Generic name
- Permanent defibrillator electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2012-01-27
- Decision date
- 2012-02-16
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
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