FINELINE II & THINLINE II
FDA premarket approval P960004/S038 · decided 2007-02-28
Approval details
- PMA number
- P960004
- Supplement
- S038
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE II & THINLINE II
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2006-08-01
- Decision date
- 2007-02-28
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- PROCESS CHANGE TO THE FINELINE II AND THINLINE II J-FORMING MANUFACTURING METHOD TO IMPROVE RETENTION CHARACTERISTICS OF THE ATRIAL J-SHAPE.
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