HULKA CLIP FOR TUBAL OCCLUSION
FDA premarket approval P870080/S001 · decided 1998-03-12
Approval details
- PMA number
- P870080
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HULKA CLIP FOR TUBAL OCCLUSION
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Richard Wolf Medical Instruments Corp.
- Date received
- 1998-01-09
- Decision date
- 1998-03-12
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Vernon Hills, IL
- Statement
- Approval for the instruction manual "Hulka Clips for Hulka Clip Applicators" - E36 to be included with each box of clips sold.
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