MODEL 0010 BIPOLAR ENDOCARDIAL LEAD
FDA premarket approval P830060/S039 · decided 1995-08-28
Approval details
- PMA number
- P830060
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 0010 BIPOLAR ENDOCARDIAL LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-05-01
- Decision date
- 1995-08-28
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE MODEL 0010 LEAD AND TO USE A "TRAY-IN-TRAY" PACKAGING SYSTEM FRO THE LEAD
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