COGNIS
FDA premarket approval P010012/S227 · decided 2009-12-22
Approval details
- PMA number
- P010012
- Supplement
- S227
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COGNIS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2009-11-27
- Decision date
- 2009-12-22
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO THE FOLLOWING: 1) DECONTAMINATION STEP; 2) WETBLASTING STEP; AND 3) IN PROCESS MONITOR FOR SPECIFICATIONS.
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