CONTAK CD/EASYTRAK
FDA premarket approval P010012/S111 · decided 2006-03-31
Approval details
- PMA number
- P010012
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTAK CD/EASYTRAK
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2006-03-03
- Decision date
- 2006-03-31
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
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