STELID II BTF/BJF STEROID COLLAR
FDA premarket approval P020030/S007 · decided 2012-03-15
Approval details
- PMA number
- P020030
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STELID II BTF/BJF STEROID COLLAR
- Generic name
- Permanent defibrillator electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-08-23
- Decision date
- 2012-03-15
- Days to decision
- 570 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR IMPROVING THE STEROID COLLAR MANUFACTURING PROCESS.
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