STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS
FDA premarket approval P020030/S004 · decided 2008-10-17
Approval details
- PMA number
- P020030
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2007-10-11
- Decision date
- 2008-10-17
- Days to decision
- 372 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A CHANGE INVOLVING ALTERNATE PROCESS PARAMETERS FOR THE MANUFACTURING OF MATERIALS IN THE STEROID COLLAR COMPONENTS.
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