FINELINE/ THINLINE
FDA premarket approval P960004/S024 · decided 2004-02-10
Approval details
- PMA number
- P960004
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE/ THINLINE
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2004-01-13
- Decision date
- 2004-02-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
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