ALTERNATE LASER SOURCE
FDA premarket approval P950029/S062 · decided 2011-09-01
Approval details
- PMA number
- P950029
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALTERNATE LASER SOURCE
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2011-08-04
- Decision date
- 2011-09-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- MODIFY THE PRE-CONDITIONING CYCLE BEFORE LASER WELDING AND THE USE OF AN ALTERNATE LASER SOURCE.
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