THINLINE ENDOCARDIAL PACING LEADS
FDA premarket approval P960004/S010 · decided 2000-03-29
Approval details
- PMA number
- P960004
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINLINE ENDOCARDIAL PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1999-09-14
- Decision date
- 2000-03-29
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the use of Nusil MED 4870 as an alternate material for the suture sleeve and extension of the shelf life of your devices to 4 years.
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