THINLINE II/ FINELINE II PACING LEADS
FDA premarket approval P960004/S012 · decided 2000-06-07
Approval details
- PMA number
- P960004
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THINLINE II/ FINELINE II PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-05-15
- Decision date
- 2000-06-07
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- FIVE MINOR CHANGES MADE TO THE THINLINE II(TM) AND FINELINE II(TM) MANUFACTURING PROCESSES.
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