ISOLINE 2CR
FDA premarket approval P980049/S039 · decided 2008-10-09
Approval details
- PMA number
- P980049
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISOLINE 2CR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-08-06
- Decision date
- 2008-10-09
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A CHANGE TO THE FINISHED DEVICE ACCEPTANCE CRITERIA AND AN ASSOCIATED LABELING CHANGE IN THE SCREW MECHANISM TEST FOR THE ISOLINE PRODUCTS.
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