INCEPTA, ENERGEN, PUNCTUA, TELIGEN, CONFIENT
FDA premarket approval P960040/S266 · decided 2012-11-14
Approval details
- PMA number
- P960040
- Supplement
- S266
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INCEPTA, ENERGEN, PUNCTUA, TELIGEN, CONFIENT
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-07-06
- Decision date
- 2012-11-14
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF AN AUTOMATED VISION SYSTEM DURING SEAL PLUG INSPECTION.
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