CONTAK AND RENEWAL FAMILIES
FDA premarket approval P960040/S126 · decided 2006-08-08
Approval details
- PMA number
- P960040
- Supplement
- S126
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTAK AND RENEWAL FAMILIES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-05-05
- Decision date
- 2006-08-08
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.
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