THINLINE ENDOCARDIAL PACING LEADS
FDA premarket approval P960004/S001 · decided 1997-08-29
Approval details
- PMA number
- P960004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- THINLINE ENDOCARDIAL PACING LEADS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1997-01-27
- Decision date
- 1997-08-29
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the ThinLine(TM) EZ Model 438-10 Endocardial Pacing Lead. This device is indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator.
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