ISOLINE 2CR PACINGS LEADS
FDA premarket approval P980049/S049 · decided 2009-07-15
Approval details
- PMA number
- P980049
- Supplement
- S049
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ISOLINE 2CR PACINGS LEADS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-06-16
- Decision date
- 2009-07-15
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ADDITION OF TWO WARNINGS REGARDING THE USE OF STRAIGHT STYLETS DURING IMPLANT PROCEDURES WITH THE ISOLINE 2CR DEFIBRILLATION LEADS.
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