BIPOLAR ENDOCARDIAL LEAD
FDA premarket approval P830060/S043 · decided 1998-11-04
Approval details
- PMA number
- P830060
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIPOLAR ENDOCARDIAL LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-10-13
- Decision date
- 1998-11-04
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes to the IS-1 terminal pin for Lead Models 0013 and 0015, and minor labeling changes.
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