THINLINE/FINELINE ENDOCARDIAL PACING LEADS
FDA premarket approval P960004/S011 · decided 2000-02-23
Approval details
- PMA number
- P960004
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINLINE/FINELINE ENDOCARDIAL PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-01-11
- Decision date
- 2000-02-23
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval to market all previously marketed Intermidics shylets kits under new Guidant modelnumbers and provide an alternate stylet kit package insert.
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