COGNIS CRT-D
FDA premarket approval P010012/S189 · decided 2008-11-17
Approval details
- PMA number
- P010012
- Supplement
- S189
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COGNIS CRT-D
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2008-07-22
- Decision date
- 2008-11-17
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.
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