ISOLINE 2CT & 2 CR
FDA premarket approval P980049/S063 · decided 2011-03-31
Approval details
- PMA number
- P980049
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISOLINE 2CT & 2 CR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2011-02-28
- Decision date
- 2011-03-31
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- UPDATE TO THE CURRENT LEADS LABEL PRINTING SOFTWARE.
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