THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS
FDA premarket approval P960004/S019 · decided 2001-10-26
Approval details
- PMA number
- P960004
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2001-10-04
- Decision date
- 2001-10-26
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO CREATE SEPARATE ACCESSORY PACKS WHICH WILL INCLUDE THE MODELS 6220 AND 6221 SUTURE SLEEVES.
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